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Vitamin D supplementation in older adults: Searching for specific guidelines

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25 ROLLAND_04 LORD_c 09/04/13 14:53 Page402

The Journal of Nutrition, Health & Aging©

Volume 17, Number 4, 2013

VITAMIN D SUPPLEMENTATION IN OLDER ADULTS: SEARCHING

FOR SPECIFIC GUIDELINES IN NURSING HOMES
Y. ROLLAND1,2, P. DE SOUTO BARRETO1, G. ABELLAN VAN KAN1, C. ANNWEILER3,
O. BEAUCHET3, H. BISCHOFF-FERRARI4, G. BERRUT5, H. BLAIN6, M. BONNEFOY7, M. CESARI1,2,
G. DUQUE8, M. FERRY9, O. GUERIN10, O. HANON11, B. LESOURD12, J. MORLEY13,
A. RAYNAUD-SIMON14, G. RUAULT15, J.-C. SOUBERBIELLE16, B. VELLAS1,2 ON THE BEHALF
OF THE FRENCH GROUP OF GERIATRICS AND NUTRITION
1. Department of Geriatric Medicine, CHU Toulouse, Institute of aging, F-31059 Toulouse, France; 2. Inserm, U1027, F-31073, Toulouse, France; 3. Department of Neuroscience,
Division of Geriatric Medicine and Memory Clinic, Angers University Hospital; UPRES EA 2646, University of Angers, UNAM, France; 4. Centre on Aging and Mobility, Department
of Rheumatology and Institute of Physical Medicine, University Hospital Zurich, Zurich, Switzerland; 5. Department of Geriatric Medicine, CHU, Hospital Bellier, Nantes, France;
6. Department of Geriatrics, University Hospital of Montpellier, Movement to Health Laboratory Montpellier, Euromov, University of Montpellier 1, France; 7. Department of Geriatric
Medicine, Hospital Lyon-Sud, Hospices Civils de Lyon, Pierre-Bénite, France; 8. Ageing Bone Research Program, Sydney Medical School Nepean, University of Sydney, Australia
9. UMR U 557, Inserm U 1125, Inra/Cnam/Paris 13, France; 10. Department of Geriatric Medicine, CHU Nice, University Nice-Sophia Antipolis, Nice, France; 11. EA 4468 INSERM,
Department of Geriatric Medicine, University Paris Descartes, AP-HP, hôpital Broca, Paris, France; 12. Department of geriatrics, CHU Clermont-Ferrand; UPRES AME2P, University of
Clermont-Ferrand, France; 13. Division of Geriatric Medicine, Saint Louis University, St Louis, MO, USA; 14. Department of geriatrics, Hôpital Bichat-Claude-Bernard, Paris, France
15. French Society of Geriatrics and Gerontology (SFGG); 16. Department of functional exploration, Hôpital Necker-Enfants malades, Assistance Publique-Hôpitaux de Paris (AP-HP),
Paris, France. Corresponding author: Yves Rolland – Gérontopôle de Toulouse, Pavillon Junot, 170 avenue de Casselardit. Hôpital La Grave-Casselardit, 31300 Toulouse, France
Telephone: +33 (0)5 61 77 64 06 Fax: +33 (0)5 61 49 71 09 Email: rolland.y@chu-toulouse.fr

Abstract: Background: The prevalence of vitamin D insufficiency is very high in the nursing home (NH)
population. Paradoxically, vitamin D insufficiency is rarely treated despite of strong clinical evidence and
recommendations for supplementation. This review aims at reporting the current knowledge of vitamin D
supplementation in NH and proposing recommendations adapted to the specificities of this institutional setting.
Design: Current literature on vitamin D supplementation for NH residents was narratively presented and
discussed by the French Group of Geriatrics and Nutrition. Result: Vitamin D supplementation is a safe and well-
tolerated treatment. Most residents in NH have vitamin D insufficiency, and would benefit from vitamin D
supplement. However, only few residents are actually treated. Current specific and personalized protocols for
vitamin D supplementation may not be practical for use in NH settings (e.g., assessment of serum vitamin D
concentrations before and after supplementation). Therefore, our group proposes a model of intervention based
on the systematic supplementation of vitamin D (1,000 IU/day) since the patient's admission to the NH and
throughout his/her stay without the need of a preliminary evaluation of the baseline levels. Calcium should be
prescribed only in case of poor dietary calcium intake. Conclusion: A population-based rather than individual-
based approach may probably improve the management of vitamin D insufficiency in the older population living
in NH, without increasing the risks of adverse health problems. The clinical relevance and cost effectiveness of
this proposal should be assessed under NH real-world conditions to establish its feasibility.

Key words: Vitamin D, nursing home, institution, resident, recommendation.

Introduction
It has been estimated that 25% of the older person aged 85
and over live in nursing home (NH) in France (1). The mean
age of NH residents is about 86 years. Most of them are
dependent in basic activities of daily living, and present
multiple comorbidities and polypharmacy. One out of five of
NH residents dies during his/her first year of stay (2).
Consistently, rates of hospitalization in NH residents are also
very high (3). Although the functioning and characteristics of
NHs in the whole health system vary across countries, similar
profiles of residents (i.e., individuals characterized by an
increased vulnerability of health status to stressors) are reported
worldwide (1).
In NH, vitamin D supplementation is rarely considered as a
health priority (2, 4, 5). Despite of the very high rates of falls
and fractures in NH residents (2), osteoporosis is largely
underdiagnosed and often remains untreated. Nevertheless, the
Received October 10, 2012
Accepted for publication November 19, 2012
402
risk of hip fractures has been estimated at 3.7 to 5.0 per 100
residents per year. This risk is about 2.5- to 10-fold greater than
that measured in community-dwelling populations (6-8). A
fourth of the fractures over the age of 75 years occurs in NH
(9). In the last two decades, numerous intervention studies and
several meta-analyses (10-15) have repeatedly reported that
vitamin D supplementation can reduce the risk of falls and
fractures in older people including NH residents.
Vitamin D is a cheap treatment for which major clinically
relevant benefits have been reported. Moreover, it is associated
with low risk of adverse events (10, 16). There is no population
with more convincing arguments to supplement with vitamin D
than NH residents (17). For physicians working in NHs, the
main challenge is to preserve functional ability and quality of
life of residents who have multiple and complex comorbidities,
polypharmacy, and reduced life expectancy. However, to reach
these goals, clinical practices in NH currently rely more on
empiricism (and sometimes even on fatalism) than on evidence-
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based medicine. Only 2% of the research published in older
populations concerns NH residents (1). Therefore, our
knowledge about the specific health care to provide for the
growing population of this institutional setting is still largely
lacking.
The aim of the present manuscript is to critically review
articles that investigated the use of vitamin D supplementation
in older persons, in particular those living in NH. Another
purpose is to promote the use of vitamin D supplementation in
NHs. We expect that the present review will increase
physicians’ awareness about the importance of vitamin D
supplementation in the care of older residents living in NHs.
This work was conducted on the behalf of the French Group of
Geriatrics and Nutrition composed by experts in the fields of
nutrition, gerontology, and geriatrics.
Prevalence of vitamin D deficiency in NH
Although different cut-points have been provided, vitamin D
levels below 50 nmol/L (or 20 ng/mL), 25 nmol/L (or 10
ng/mL), and 12.5 nmol/L (or 5 ng/mL) are generally considered
to define vitamin D insufficiency, deficiency, and severe
deficiency, respectively (18). Epidemiological studies have
reported that many older people, especially those living in NH,
present vitamin D deficiency (18-33). In fact, the vitamin D
insufficiency has even reached the 100% prevalence in some
studies in institutionalized older persons (34). Consistent data
have been reported from different countries worldwide in NH
populations (18-33) (See Table I for a summary of 25(OH)-
vitamin D levels in nursing homes). The age-related reduction
of cholecalciferol production in the skin, the limited exposure
to direct sunlight, and the inadequate nutritional intake
represents the main reasons for such phenomenon in NH (35).
The high prevalence of vitamin D insufficiency is widely
reported and stable since decades in spite of education efforts
and expert recommendations proposing the increase of vitamin
D intake in NH (36). For example, mean 25(OH)-vitamin D
levels of a sample of homebound subjects living in NH or in the
community was 33.25 nmol/L (or 13.3 ng/mL) in the United
States (37). Other studies reported that about 60% of NH
residents presents a level of 25(OH)-vitamin D below 50
nmol/L (or 20 ng/mL) (38, 39). In a very recent study
conducted in Austria, Piltz et al. showed that 92.8% of the 961
residents from 95 NH had vitamin D insufficiency (40). In the
Netherlands, vitamin D level was found to be insufficient in
98% of the NH residents (27). Even in Australia or in the
Southern Greece, countries with high sunlight exposure, similar
prevalence of vitamin D insufficiency was reported among NH
residents (26, 32, 41, 42). These findings suggest that a
population-based vitamin D supplementation should be
carefully considered in this population. Levels below 25
nmol/L (or 10 ng/mL) have been found in from 18% to 73% of
nursing home residents with 10 out of 12 studies reporting a
more than 30% of the population showing deficiency.
403
Background of vitamin D supplementation in the NH
The low prescription rate of vitamin D in NH residents is
noteworthy. This unjustified undertreatment relies on wrong
assumptions such as the lack of utility of a long-term treatment,
the poor tolerance of patients to the supplementation, and
polypharmacy issues due to the frailty or disability status (43).
However, these assumptions are not supported by the available
evidence (4, 43).
The prevalence of use of vitamin D supplements in NH
varies among countries (and even among regions within the
same country), but it constantly remains low. Vitamin D
supplements were prescribed to 10.3% of NH residents in
Australia (44), 6.2% in Austria (45), 7.0% in Spain (46), and
14.6% in France (47). In the United States, only one third of all
residents of a New York university NH received vitamin D
supplementation (48). In Arkansas, among 177 residents in a
nursing facility, only 9% were prescribed vitamin D (49).
Similarly, only 5% of 1,427 NH residents in Maryland were
reported to receive vitamin D supplementation (50). In a large
sample (n=186,221) of NH residents in Kansas, Maine,
Missouri, Ohio, and South Dakota, Wright et al. reported that a
combination of calcium and vitamin D supplements was
prescribed to only 3.4% of residents (51). Moreover, when
prescribed, the dosage of vitamin D supplement is often too
low. In Finland, although 32.9% of the NH residents received
vitamin D supplementation, only 3.6% received the
recommended dose of 800 IU per day (52).
The prescription of vitamin D is strongly associated with the
diagnosis of osteoporosis. In fact, the prevalence of
supplementation increases when a diagnosis of osteoporosis is
reported. As indicated by Colon-Emeric et al. in a study
investigating 67 NHs, 69% of residents with osteoporosis or
who recently experienced a fracture received vitamin D
supplementation (53). Other studies also found higher use of
vitamin D supplementation in persons with osteoporosis (48).
In this context, it is important to recognize that the diagnosis of
osteoporosis itself still remains largely under recognized in NH
(4), potentially contributing to the limited use of vitamin D
supplementation.
The optimal vitamin D requirement for elderly individuals
remains unclear. Quantity, quality and procedures to deliver
vitamin D in NH residents are not univocally established. Most
guidelines and recommendations propose to continuously
supplement all the institutionalized older persons, given the
very high prevalence of vitamin D deficiency in the NH
residents (Table 2). Moreover, higher doses of supplementation
have been recommended in this population compared to what
usually suggested in younger adults (4, 54-56).
Available recommendations are largely designed considering
the prevention of bone resorption as the primary endpoint of
interest and also as a co-adjuvant of all osteoporosis treatments.
The level of parathyroid hormone increases when blood level of
25(OH)-vitamin D is lower than 50 nmol/L (or 20 ng/mL).
However, vitamin D requirement may be best defined by a
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Table 1
Prevalence of 25(OH)-vitamin D Deficiency in Nursing Home Residents

Author Country Year n 25(OH)-Vitamin D

Egsmose et al (135) Denmark 1987 94 50% <12.5 nmol/L. Note: 400 IU VD* produced normo-calcemia
but did not normalize PTH or alkaline phosphatase
Sem et al (136) Norway 1987 35 83% of women and 77% of men <50 nmol/L. Note: Supplement
users had values >20 ng/mL
Webb et al (137) USA 1990 211 29% <25 nmol/L in non VD users and 3% <25 nmol/L in VD users
Note: VD use (400IU) kept levels >37.5 nmol/L in 95%
Hemmelstein et al (138) USA 1990 30 50% <50 nmol/L
McMarty et al (31) USA 1992 57 mean VD level: 43.75 nmol/L
Löwik et al (139) Holland 1992 51 73% <25 nmol/L
O’Dowd et al (33)† USA 1993 109 VD intake 200-400 IU: 40% <37.5 nmol/L
VD intake 400 IU†: None <37.5 nmol/L
Komar et al (140) USA 1993 109 86% <50 nmol/L
Stein et al (141) Australia 1996 99 52% <28 nmol/L
Plantalech et al (142) Argentina 1997 77 40.5% <25 nmol/L
Kinyamu et al (143) USA 1997 60 8% <12 nmol/L
Liu et al (24) Canada 1997 155 9% in fall and 18% <25 nmol/L in spring
38% in fall and 60% <40 nmol/L in spring
Stein et al (42) Australia 1999 83 mean VD level: 27 nmol/L. Note: Values lower than in those who
fell
Krieg et al (144) Switzerland 1999 103 mean VD level: 11.8 nmol/L. Note: 440 IU of VD3 for 2 years
increased bone broadband ultrasound attenuations
Nashimoto et al (145) Japan 2002 220 57.9% <30 nmol/L
Elliott et al (38) USA 2003 49 60% <50 nmol/L
Sambrook et al (146) Australia 2004 637 73.6% <39 nmol/L. Note: VD associated with falls
Flicker et al (41)* * Australia 2005 625 58% <40 nmol/L. Note: 1,000 IU daily or10,000 IU VD weekly
reduced falls and fractures in those <25 nmol/L
Drinka et al (147) USA 2007 302 32% <75 nmol/L
Hamid et al (35) USA 2007 44 16% <50 nmol/L
Rinaldi et al (148) Indonesia 2007 62 22.6% <50 nmol/L
Chel et al (27) Holland 2008 338 98% <50 nmol/L
Pérez-Llamas et al (46) Spain 2008 86 58.2% <50 nmol/L and 32.6% <25 nmol/L
Papapetrou et al (26) Greece 2008 58 mean VD level: 19 nmol/L
Braddy et al (149) USA 2009 229 37% <50 nmol/L
Terabe et al (19) Japan 2012 403 49.1% <40 nmol/L
Pilz et al (40) Australia 2012 961 93% <50 nmol/L
Verhoeven et al (150) Belgium 2012 589 75.6% <50 nmol/l
Kruavit et al (151) Thailand 2012 93 38.7% <20 nmol/L

* vitamin D; ** Persons less than 25 nmol/L excluded; † Appears to be same population;Vitamin D levels below 50 nmol/L define vitamin D insufficiency, below 25 nmol/L define
deficiency, and below 12.5 nmol/L define severe deficiency [18] (2.5 nmol/L = 1 ng/mL).

blood level of 25(OH)-vitamin D rather than an increased level
of PTH. Interestingly, a meta-analysis of randomized clinical
trials showed that a higher concentration of 25(OH)-vitamin D
(i.e., above 72 nmol/L or 29 ng/mL) is required in order to
prevent bone fractures (10). An optimal level of 75 to 100
nmol/L (or 30 to 40 ng/mL) of 25(OH)-vitamin D has been
indicated by several groups of experts as the optimal range to
prevent fracture events and maintain health benefits (57, 58).
Studies in groups of young and old people generally show that
blood concentrations of 75 to 100 nmol/L (or 30 to 40 ng/mL)
of 25(OH)-vitamin D may be achieved with daily
supplementation of 700 IU to 1000 IU of vitamin D (17, 59,
60), although some persons may require higher dosages (61). It
has been calculated that a daily vitamin D3 supplementation
with 2000 IU may bring the vast majority of elderly people to
the desired level (61). This is a dosage that is well-below the
threshold usually considered as toxic in older persons (i.e.,
4,000 IU/day) (62). However, further studies are needed to
validate such data and confirm these dosages.
Most of the current guidelines generally advise that
institutionalized older individuals should receive a
supplementation of at least 1,000 IU of vitamin D per day to
achieve the optimal vitamin D status (Table 2). At this dosage,
the majority of residents, including those with the highest
requirement of vitamin D supplementation, should meet their
needs. Nevertheless, the patient's baseline level of vitamin D,
skin pigmentation, and amount of adipose tissue may influence
the capacity to adequately responding to the treatment. Taking
into account such variability of the population, the working
group of the American Geriatric Society has proposed a daily
dosage of 1,000 IU of vitamin D per day, plus individualized
supplementation according to sun exposure, skin pigmentation,
and obesity (Table 1).

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Table 2
Current guidelines and recommendations for vitamin D supplementation, proposed by different groups and applicable in NH

Guidelines and recommendations Years Recommended Vitamin D supplement dosages

American Geriatrics Society (119) 2012 At least 1000 IU/day

National Academy of Medicine (France) (152) 2012 At least 1500 IU/day
American Endocrine Society (84) 2011 1500 to 2000 IU/day
Institute of Medicine (United State) (54) 2011 800 IU/day
Scientific Advisory Council of Osteoporosis in Canada (153) 2010 800 to 2000 IU/day
United State preventive Services Task Force (154) 2010 800 to 1000 IU/day
Consensus recommendations in Australia (116) 2010 1000 IU/day
International Osteoporosis Foundation (55) 2010 800 IU/day
Expert working group on Vitamin D (56) 2010 800 IU/day
Society for Sarcopenia, Cachexia, and Wasting Disease (155) 2010 Vitamin D should be supplemented in all persons with values less than
100 nmol/L (or 40 ng/mL)
Expert working group on Vitamin D (35) 2007 800 to 1000 IU/day of vitamin D3 or the bolus equivalent
administered as 50,000 IU D2 doses every 2 months
Expert working group on Vitamin D (156) 2007 1000 IU/day
Japan Osteoporosis Society (157) 2006 200 à 400 IU/day
Nordic Nutrition Recommendation (158) 2006 800 IU/day
American Medical Director Association (159) 2005 800 to 1000 IU/day
The National Kidney Foundation’s Guidelines (US) (160) 2003 PTH level should be determined if the glomerular filtration rate is less
than 60 ml/min. If PTH is elevated, the 25(OH)-vitamin D level
should be determined. If that level is 75 nmol/L (or <30ng/mL),
supplementation with vitamin D should be initiated to achieve a target
level of 75nmol/L (or <30 ng/mL).
British Geriatrics Society Falls and Bone Health Special Interest 2003 Use of vitamin D supplements in all nursing/residential home
Group (161) population.
FAO/WHO, Recommended Nutritient Intake (162) 2001 600 IU/day
Recommended Dietary Intake in France (163) 2001 600 IU/day
Referenzwerte in Germany, Switzerland, Austria (164) 2000 400 IU/day
Current Care guidelines in Finnish (165) 2000 700 to 800 IU/day
Dietary Reference Value, Recommended Nutritient Intake in United 1998 400 IU/day
Kingdom (166)
Dietary Reference Intake and Adequate Intake in the United States of 1997 600 IU/day
America and Canada (131)

Note: IU, International Unit; FAO, Food and Agriculture Organization; WHO, World Health Organization; PTH, parathormon.

What can we expect from vitamin D supplementation in NH
residents?
A recent study has suggested that the lowest rate of mortality
is associated with 25(OH)-vitamin D of 75 to 87.5 nmol/L (or
30 to 35 ng/mL) (63). There is evidence that higher vitamin D
levels decreased cardiovascular mortality (64, 65). Increased
mortality has been found when 25(OH)-vitamin D levels are
greater than 98 nmol/L (or 39.2 ng/mL) (66). Research
evidence supports that vitamin D can reduce bone turnover,
incidence of falls, risk of bone fractures, and improve balance
and muscle strength (10, 67-70). In particular, a large number
of randomized controlled trials (RCT) and several meta-
analyses have reported that supplementation of vitamin D,
when administered at sufficient dosages, reduces the risk of hip
fracture by 13% to 26% in older NH residents (10, 11, 13, 14,
71-73). For example, a recent meta-analysis pooling data from
31,022 individuals shows that vitamin D supplementation (at
least 800 IU/day) has clinically significant effects on fracture
reduction (30% less hip fractures) (12).
However, data from several study-level meta-analyses and
one pooled individual participant-level (IPD) analysis are
conflicting. While one trial-level meta-analysis of double-blind
randomized trials (RCTs) suggested an 18% reduction of hip
and 20% reduction of any non-vertebral fractures at a received
dose of no less than 482 IU vitamin D per day (11), three study-
level meta-analyses (15, 74, 75) and one pooled analysis of IPD
(76) from open design and blinded trials, suggested that vitamin
D may have a neutral effect on total fractures (74), or may
reduce hip fractures by 7 to 16 % independent of its dose if
combined with calcium supplementation (15, 74, 75). The
discordant findings may in part be explained by different
inclusion criteria of trials with respect to blinding and intake
form (oral, injectable), or different accommodations for
adherence.
Similarly, some well-designed RCTs individual trials
included in these meta-analyses, did not report a reduction in
the incidence of fractures among older people living in
institutional care after supplementation with four-monthly
100,000 IU of oral vitamin D2 (77) or equivalent daily dosages
(78), while another large trial with 800 IU vitamin D3 per day
(16) showed a significant 43 percent reduction in hip fracture
risk among nursing home residents Moreover, another recent
study showed that high dosages of vitamin D once a year

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(500,000 IU of cholecalciferol) ambulatory post-menopausal
women was associated with a significant increase of risk for hip
fracture (73). These discrepancies may, at least partly, explain
why physicians are discouraged at adopting systematic
supplementation of vitamin D in NH residents. However, the
large range of dosages used in the current evidence, the
supplementation of non-deficient individuals, the possible use
of vitamin D2 supplements, and the variable rates of
adherence/compliance to the treatment may explain the
different available results (79). Studies that have used high
dosages of vitamin D (700 to 800 IU per day) with or without
calcium were more likely to be effective in preventing hip
fracture (79). Trials with compliance rates of >80%, developed
for people aged 70 years and older (especially in NH residents)
were likely to report greater benefits from vitamin D
supplementation (15).
It is possible that vitamin D supplementation seems
particularly effective in NH residents because of their more
severe deficiency, their lower dietary intake, and their better
compliance to the intervention (80). In this context, it is
noteworthy that while supplementation of vitamin D seems to
improve both strength and physical performance in deficient
older persons (81, 82), little or no effects are reported in
individuals with normal concentrations of 25(OH)-vitamin D
level (83), unless much higher 25(OH)-vitamin D levels are
reached as tested in a small trial among early postmenopausal
women (84).
Observational studies suggest that vitamin D may represent a
key factor for promoting general health, even beyond its
specific role played on bone and muscle tissues. In fact, vitamin
D deficiency may play a pathophysiological role in
cardiovascular (85, 86), cognitive (87), immunological (88),
dental (89) and oncological (90) conditions, which are highly
prevalent in NH residents (91). The general health benefits of
vitamin D supplementation may also potentially include the 7%
decreased risk of mortality reported in a meta-analysis of
clinical trials (92), an association confirmed also in NH patients
(40) and among senior hip fracture patients followed for 12
months after their fracture (93).
Vitamin D safety
The long-term safety and side effects associated with drug
consumption are important sources of concern, especially in
NH population. The fear of potential toxicity due to excessive
vitamin D supplementation currently poses a barrier for the
optimization of a standard nutritional policy (94). Vitamin D
has potential health benefits, but it may also adverse effects if
given in too high doses.
The large majority of available randomized controlled trials
and reviews support that vitamin D supplementation is safe and
well-tolerated. In a 2010 risk benefit assessment of vitamin D, a
safe upper intake of up to 10,000 IU per day has been suggested
406
based on the risk of hypercalcemia (56), which was the basis of
the new safe upper intake recommendation of 4000 IU vitamin
D per day among adults by the Institute of Medicine (safety
factor of 2.5). Further, it has been reported that up to 4,800
UI/day of vitamin D (up to one year) result in no adverse events
(62). Other authors have reported that administration of up to
11,000 IU/day of vitamin D3 for 5 months did not result in
serum calcium levels rising above the normal range (95).
Moreover, it is commonly reported the absence of significant
differences for the incident rates of adverse events between
control and vitamin D supplementation groups (41, 78, 96).
Rapid repletion of vitamin D levels should be avoided. Some
authors did not reported an associated between a rapid repletion
and an increased risk of side effects in a frail older persons
(97). However, Sanders et al. showed the time dependent risk in
the first 3 months of application of a 500,000 IU of vitamin D
supplementation of frail elderly women at risk of fracture (73).
These results have led the recent recommendations not to
supplement with large bolus doses.
In practice, supplementation at high dosages, such as 2000
IU/day, is very unlikely to be associated with any toxicity (56,
98), also documented in detail in one 12-month double-blind
RCT among acute hip fracture patients with a mean age of 84
years (56). Based on recent researches, the theoretical dose of
250 microg/d (or 10,000 IU/day) of vitamin D3 is proposed to
be the highest intake a person may safely take (56, 99). This
threshold is far above the 2000 IU/day usually proposed by
international authorities and expert groups such as the Food and
Nutrition Board (100).
Unfortunately, most of the available data rely on studies
focused on healthy older adults. Further studies are needed to
better define the safety threshold of vitamin D intake in order to
maximize the positive effects of the intervention (101).
In studies using high dosages of vitamin D, the increased
concentrations of serum 25(OH)-vitamin D did not follow a
linear trend, but drew a curvilinear response suggestive of a
rate-limiting mechanism (62). Moreover, very high dosages of
vitamin D supplementation have been associated with increased
risk of adverse events. In 2010, a large double-blind RCT by
Sanders et al., including 2256 community-dwelling women age
70 years and older, tested the benefit of 500,000 IU vitamin D3
given orally once a year, on fall and fracture prevention (73). In
those women, mean age 76, considered to be at risk of fracture,
500,000 IU vitamin D once a year did not reduce but increase
the risk of falls by 15% and the risk of fractures by 26%
compared to placebo, with the greatest increase in falls
occurring during the first 3 month after dosing. These findings
are consistent with another trial that tested 300,000 IU vitamin
D2 as an intra-muscular injection once a year (14).
Whether the large dose of vitamin D tested in the Sanders
trial was too much of a good thing or not enough to provide a
sufficient supply of vitamin D over 12 months is speculative
(102). The temporal pattern of events may suggest that the high
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dose of vitamin D may have induced a “protective” reaction
resulting in an acute decrease in 1,25-dihydroxyvitamin D
(103). Alternatively, the undocumented potential effect of
vitamin D on muscle strength (104) and overall health (i.e. less
infections and less hospital admissions (105)) in the Sanders
trial, may have improved mobility and decreased “down time”,
ironically leading to an increased opportunity to fall and
fracture.
As a result of the Sanders trial and given the half-life of
vitamin D is 3 to 6 weeks, a daily, weekly, or monthly dosing
interval may be most advantageous and safe (11, 27).
Calcium safety
Calcium is frequently associated with vitamin D in the
treatment of osteoporosis, and may be responsible of adverse
reactions. For example, the combination of calcium and vitamin
D may alter the incidence of kidney stones. In the Women's
Health Initiative (WHI) RCT, vitamin D supplementation (at a
dosage of 400 IU/day) significantly increased the risk of kidney
stones (106) and cardiovascular events (107), especially among
individuals who take calcium supplements although their intake
from diet is sufficient (800 to 1000 mg/day).
Notably, in two meta-analyses of randomized trials of
calcium supplements alone compared with placebo there was
no significant effect on fracture risk (14, 39). In fact, in one
meta-analysis of 4 double-blind RCTs calcium supplementation
at a dose between 600 and 1200 mg per day increased the risk
of hip fracture significantly by 64% compared with placebo
(39).
In contrast to calcium supplements, dietary sources of
calcium are not associated with an increased risk of
cardiovascular disease and are recommended in combination
with vitamin D supplementation. Further, larger cohort studies,
mechanistic studies and small clinical trials support a
cardiovascular-protective effect of vitamin D (64, 108).
Risk of active vitamin D metabolites
Active forms of vitamin D, i.e., 1,25(OH)-vitamin D
(calcitriol or analogs), have been investigated in 2 meta-
analyses with significant benefits on both falls (109) and
fracture reduction (11). However, this benefit was not superior
to vitamin D supplementation at a dose between 700 to 1000 IU
per day.
Further, active vitamin D metabolites, especially in older
individuals with renal failure may be associated with an
increased risk of hypercalcaemia (110-113).
Should calcium be systematically associated with vitamin D
Most meta-analyses suggested that the dose of vitamin D is
irrelevant when vitamin D is combined with calcium (15, 74-
76). In contrast, a most recent pooled meta-analysis of 8
407
double-blind RCTs that combined vitamin D with calcium
supplements found that fracture reduction was present only at
the highest actual intake level of vitamin D (792 to 2000
IU/day: median = 800 IU/day). Further, the authors’ findings
suggest that at the highest actual intake level of vitamin D
supplementation, a calcium dose <1000 mg/d may be preferred
to a higher dose of calcium for fracture reduction. These
findings are in line with epidemiologic studies suggesting that
with sufficient vitamin D intake, a higher calcium intake may
not be correlated with bone health (114, 115).
Including these most recent data and the potential risk of
calcium supplements, calcium supplementation may be harmful
in seniors who get enough calcium through their diet. Further,
Calcium supplements have frequent side effects such as
constipation, anorexia, and gastrointestinal irritation in older
persons. This is also generally associated with a negative
impact on long-term adherence to the treatment of osteoporosis
and the global dietary intake. Calcium supplementation should
be driven by daily dietary intakes from dairy products and
patient’s specific tolerance. Calcium supplementation should be
carefully considered, especially in residents with history of
kidney stones and risk factors for cardiovascular events (116).
In other words, calcium requirements may be simply reached
with diet in the NH and calcium supplementation should be
prescribed only in case of specific malnutrition.
Testing vitamin D levels before and during supplementation
One approach to identify and manage vitamin D
insufficiency is by determining its presence by measuring
serum 25(OH)-vitamin D concentrations and then use the
specific supplementation according to the patient's needs.
Specific formulas (for example, based on the Heaney’s
regression analysis (95)) may be used to facilitate the reaching
and maintenance of normal concentrations of 25(OH)-vitamin
D (117, 118). This approach is rigorous and precise, but not
easy to implement in NH because it implies the assessment of
all the residents as well as a familiarity of the coordinating
physician with the specific vitamin D protocols. Moreover,
promotion of this clinical intervention is likely to be more
successful if a unique, common, and standardized approach is
always adopted for every NH resident. The rationale for the
assessment of vitamin D status resides in the large variability of
vitamin D. Such heterogeneity of results is largely explained by
exogenous factors (such as sunlight exposure or previous
supplementation), which are not particularly relevant in NH
residents (who live in the same environment and have similar
lifestyles). Therefore, improving the vitamin D status of NH
residents with a common and standardized approach seems
more suitable and feasible rather than looking for an resident-
tailored and more expensive methodology (57).
In this context, it is also noteworthy that the assessment of
vitamin D concentrations in NH residents has repeatedly been
discouraged (117-119). Souberbielle and colleagues proposed
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that dark-skinned or veiled individuals, older persons, and
institutionalized individuals could be supplemented without the
need of previous testing of vitamin D concentrations (117,
118). The assessment of vitamin D concentrations may rather
be conducted after at least 3 months of daily supplementation to
monitor levels (117, 118). Just recently, the American
Geriatrics Society (AGS) also revised its recommendations for
vitamin D supplementation (119), stating that routine
laboratory testing for 25(OH)-vitamin D concentrations before
starting supplementation is not necessary in NH populations.
The AGS recommendations also indicate no need of monitoring
25(OH)-vitamin D for safety or efficacy reasons if
supplementation is conducted at recommended dosages.
Moreover, monitoring of serum concentrations of 25(OH)-
vitamin D should be done at least after 4 months of vitamin D
supplementation (119). Another justification to avoid
measuring vitamin D is that substantial inter-assay differences
in performance between most common commercially available
assays have been reported (120).
Given the probable cost-effectiveness and safety of the
intervention, a population- rather than an individual-based
approach for vitamin D supplementation without need of
preliminary monitoring of the serum concentrations seems
acceptable for NH residents.
Proposals for NH care
On the basis of the present narrative review, our group
proposes the following recommendations to encourage a wider
use of vitamin D supplementation in NH residents. These
recommendations represent an attempt to simplify the clinical
translation of current evidence in the difficult (and largely
unexplored) field of NH patients. Given the limitations of
current evidence, alternative approaches to improve the vitamin
D status of NH patients might be amenable as well if based on
scientifically sound rationales and methodologies.
Proposal 1
Who should be treated in the NH?
All NH residents should be supplemented. For safety
reasons, this recommendation may exclude residents at risk of
hypercalcaemia (such as residents with sarcoidosis, or
myeloma). Although current evidence does not fully support
this statement, our group believes that bedridden residents, who
are not exposed to falls, may also benefit from vitamin D
supplementation as vitamin D has more benefits than just the
prevention of non- vertebral fracture, and may support their
rehabilitation and mobilization. Vitamin D supplementation
may also be relevant for residents in palliative care or with
short life expectancy (i.e., less than 6 months) especially if they
are still mobile.
408
Proposal 2
When should residents be treated?
We suggest supplementing residents on admission to the
NH. The supplementation should be conducted during their
entire NH stay. Transition periods (e.g., the time immediately
following NH admissions) have a particularly higher rate of
negative health-related events (121). Prevalence of vitamin D
supplementation may be proposed as a quality indicator of the
preventive policy (122).
Proposal 3
Should baseline serum 25(OH)-vitamin D level be
measured?
Our group recommends the implementation of vitamin D
supplementation without previous assessment of vitamin D
concentrations given the high prevalence of vitamin D
deficiency in NH residents. Moreover, the measurement of
25(OH)-vitamin D concentrations is expensive compared to the
cost of vitamin D supplementation (about two- to three-fold
higher compared to the cost of an annual treatment of vitamin
D in Europe).
Proposal 4
Which kind of vitamin D should be used?
As vitamin D requirements cannot be reached by diet (123),
25(OH)-vitamin D concentrations relies on specific
supplements, especially in older persons. Both vitamin D2
(ergocalciferol) and vitamin D3 (cholecalciferol) present
similar effects on serum concentrations of 25(OH)-vitamin D
when daily administered (124). However, vitamin D2 has a
shorter plasma half-life than vitamin D3 (125-127). Thus,
vitamin D3 may be more suitable than vitamin D2 for
intermittent supplementation. For this reason, our group
recommends the use of vitamin D3. It should be recognized that
fortification of bread or orange juice can be equally effective in
raising serum 25(OH)-vitamin D levels (128).
In healthy young adults, a one day sunbath can produce large
amount of endogenous vitamin D (doses equivalent to an oral
intake of up to 10000 to 14000 IU of vitamin D) (117). Sunlight
exposure has beneficial effects on the NH residents’ overall
health status, in addition to the specific vitamin D production
(129, 130). Unfortunately, the organization of systematic
sunbaths to NH residents may be particularly challenging
especially during the cold seasons. Moreover, half body sun
exposure once a week during 2 months was shown to be
insufficient for reaching normal concentrations of vitamin D in
NH residents (129). This result may probably be also due to the
lower effect of sunlight on older persons' skin. Finally, it cannot
be ignored the risk of skin cancer due to sunlight exposure,
which becomes higher in elders. Also, seniors tend to avoid the
sun and produce 4 times less vitamin D in their skin under
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sunshine exposure if compared to young adults (84).
Proposal 5
What dose of vitamin D should be prescribed?
Evidence supports that daily oral supplementation with
1,000 IU of vitamin D is associated with reduction of falls and
fractures in NH residents (41). This dosage is far below the
threshold indicated as associated with increased risk of adverse
effects (10,000 IU/day) reported by The Food and Nutrition
Board (131). Very high intermittent dosage (such as 500,000 IU
per year or 200,000 IU every 4 months) should also be avoided.
Therefore, our group proposes supplementing with 1,000 IU of
vitamin D per day. This proposal is in accordance with the
recent AGS recommendations which indicate such daily dosage
as the minimum for older subjects (119). It has been reported
that 1,000 IU/day is sufficient at maintaining the target
concentration of 25(OH)-vitamin D of at least 50 nmol/L (or 20
ng/mL) and will shift at least 50% within the range of 70 and
100 nmol/L (or 28-40 ng/mL) (132). Specific recommendations
for obese or dark-skin residents are to be established: these
populations may require higher dosages.
At the individual level, it is recognized that a dose of 1,000
IU/day will take a very long time to correct serum levels in a
very deficient resident and thus to prevent adverse events
associated with vitamin D deficiency. However, at the NH
level, our approach would benefit for all NH population
without side-effect.
Proposal 6
What protocol of administration may be proposed?
A practical and easy-to-implement protocol is required in
NH. The supplementation should be administered without
individual assessment, or complex monitoring and adjustments.
Currently, different protocols can support the correction of
vitamin D insufficiency and maintenance of normal values.
However, these protocols are relevant for personalized care, but
likely too complex and not feasible in the daily routine of
institutional settings. For example, all of them rely on the
preliminary assessment (and follow-up monitoring) of 25(OH)-
vitamin D concentrations (56, 133). These protocols have
existed for years and have not been implemented by NH staff
(2). A controversy exists whether supplementation should be
continuously (e.g., daily) or intermittently (e.g., weekly,
monthly, quarterly) conducted to achieve the maximal benefits.
In the absence of definitive data on this specific topic, the
intermittent supplementation might be preferred. In fact, it has
the dual advantage of improving compliance, and reducing both
daily poly-pharmacy and the burden of the NH personnel.
The recommended target of 25-hydroxyvitamin D
concentrations ranges between 75 and 100 nmol/L (or 30 to 40
ng/mL) (132). Our group proposes starting with an oral bolus of
100,000 IU followed by 100,000 IU every 3 months.
409
Alternative protocols may include the monthly supplementation
of 50,000 IU, or even other dosages (always maintaining the
amount of supplemented vitamin D to an equivalent of 1,000
IU per day).
Proposal 7
Should calcium be added to the vitamin D
supplementation?
Calcium should not be systematically prescribed. Current
calcium DRI are 1,200 mg per day in older adults (131, 134). If
calcium intake is lower than 1,200 mg per day, consequent
modifications should be made to the diet. An adequate calcium
intake should be indeed present in the diet of NH residents.
Calcium supplementation should be prescribed to those
residents that do not still reach the desirable intake despite of
diet modifications, and rarely higher doses than 500 mg/day are
needed. Given the adverse events associated with high dosages
of calcium supplementation, caution is required before
implementing an intervention specifically modifying calcium
concentrations (134).
Proposal 8
How should vitamin D be monitored in NH population?
In a disabled population with multiple comorbidities, the
exact correction of 25(OH)-vitamin D concentrations is not
considered a priority. Our proposal is aimed at ensuring a
sufficient vitamin D status to the vast majority of NH residents.
Consistently with other panels of experts (116, 119), our group
does not support follow-up monitoring of 25(OH)-vitamin D
concentrations. The assessment of 25(OH)-vitamin D
concentrations should only be performed when vitamin D
intoxication is suspected.
Perspectives and future research
The present recommendations for the use of vitamin D
supplementation in NH older residents are designed by the
French Society of Geriatrics and Gerontology (SFGG).
Moreover, they have been included in the SFGG tool designed
for training healthcare professionals in NHs (i.e., MobiQual,
Mobilization for Quality of care). The primary aim of
MobiQual is to improve quality of life of older persons
(including NH residents) by adhering to healthy diet
recommendations. The MobiQual is supported by the Caisse
Nationale de Solidarité pour l'Autonomie (i.e., the French
national healthcare agency for older persons) and the French
Minister of Health.
There is still a lack of knowledge on vitamin D
supplementation, and further studies are needed in this area.
Intense controversies currently exist on vitamin D
supplementation, especially when the target population is
composed by frail older persons (as NH residents). The ratio of
risks/benefits of vitamin D supplementation needs to be
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NURSING HOME AND VITAMIN D
carefully explored in specifically designed, long-term RCTs
recruiting older persons (including those with increased
vulnerability to stressors).
In conclusion, our population- rather than individual-
directed approach represents an attempt to provide an
immediate answer to the need of treating a common (as well as
detrimental) clinical condition in an extremely understudied
population. Of course, although based on a scientific rationale
and on the available evidence, our recommendations should
find confirmation in specifically designed trials, and be
validated in complex "real world" of NH. The need of
developing research with the specific aim of solving the never-
ending "evidence-based medicine" issue existing in geriatric
medicine is urgent.
Acknowledgments: The authors report no conflict of interest.
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