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To,

The Director,
Research, Training and Monitoring Cell,
College of Physician and Surgeons, Pakistan.
7th Central Street Phase II, DHA,
Karachi-75500.
Kindly find enclosed here within the research protocol title: COMPARISON OF WEIGHT GAIN IN
SEVERE PRIMARY MALNOURISHED CHILDERN TAKING F-75/F-100 FORMULA DIET
VERSUS SUJI.
Prepared by:

Dr. Shazia Mandokhail

As a pre-requisite for FCPS-II in (subject) of:


is submitted on:
RTMC allotted Registration No:
Enrolment Number is:

Paediatrics

PED-2010-001-1907
F-08-8480

Trainees Signature:
Name of the Supervisor:
Qualification:
Designation:

Prof. Dr. Abdul Bari


MBBS, MCPS, FCPS
Professor

Name of the Training Institute: Bolan Medical Complex Hospital Quetta


Department:

Signature of Supervisor

Paediatric Medicine

Official Stamp: ______________________

SYNOPSIS

COMPARISON OF WEIGHT GAIN IN SEVERE PRIMARY


MALNOURISHED CHILDERN TAKING F-75 F-100 FORMULA
DIET VERSUS SUJI.

BY:
Dr. Shazia Mandokhail

SUPERVISOR:
Prof. Dr. Abdul Bari

DEPARTMENT OF PAEDIATRIC
Unit-1, Bolan Medical Complex Hospital, Quetta.

TO WHOM IT MAY CONCERN

It is to certify that enclosed synopsis with title COMPARISON OF


WEIGHT GAIN IN SEVERE PRIMARY MALNOURISHED CHILDERN TAKING F-75
F-100 FORMULA DIET VERSUS SUJI. is only being selected by my trainee Dr.

Shazia Mandokhail, having Reg #: PED-2010-001-1907 and resident for FCPS


Part-II trainee in Bolan Medical Complex Hospital, Quetta. I hereby certify that
her topic is not being duplicated or under work of any other trainee.

Date:

Signature of Supervisor

COMPARISON OF WEIGHT GAINS IN SEVERE PRIMARY


MALNOURISHED CHILDERN TAKING F-75/ F-100 FORMULA DIET
VERSUS SUJI.
INTRODUCTION
Child malnutrition is a major public health and development concern in most of the poor
communities leading to high morbidity and mortality (1). In preschool children it is a significant
problem and has been identified by the World Health Organization (WHO) as the most lethal
form of malnutrition, indirectly or directly causes an annual death of at least 5 million children
worldwide(2). The incidence of child undernutrition is high around the world, particularly
alarming in the developing countries(3-5). In Pakistan more than 38% of the children are under
weight and stunted(6).
Infants and young children are the most vulnerable as they require extra nutrition for growth and
development, have comparatively limited energy reserves and depend on others. Undernutrition
can have drastic and wide-ranging consequences for the child's development and survival in the
short and long term(7).In South East Asia children, the prevalence of adequate intakes of

micronutrients ranged from a mean of 0 for calcium to 95% for vitamin B-6 and was <50% for
iron, calcium, riboflavin, folate, and vitamin B-12(8).
WHO has issued guidelines for the management of children with severe malnutrition(9). The
World Health Organization (WHO) recommends nutritionally adequate complementary feeding
(CF) through the introduction of indigenous foodstuffs and local foods while breastfeeding for at
least 2 years(10). Indian workers have found that home based management using home prepared
food and hospital based follow up is associated with sub-optimal and slower recovery(11).
Ready-to-use therapeutic food (RUTF) is recommended by the World Health Organization for
community-based management of uncomplicated forms of severe acute malnutrition(12).
Modern in-patient dietary treatments are based upon the F75 formula whilst the child is sick
without an appetite, followed by F100 for rapid gain of weight(13). In Africa locally made
RUTFs were as effective as imported RUTFs (WMD=0.07 g/kg/d; 95% CI=-0.15, 0.29), further
energy intake with RUTF to be comparable to F-100(14).
The Unavailability of F-75 andF-100 is a ubiquitous and perennial issue. To resolve the problem
this study was designed to see if the weight gain with traditional RUTF is equal and better
compared to F-75and F-100. Considering the high prevalence of malnutrition in Balochistan, it is
imperative that local protocols incorporating local RUTF be designed to treat malnutrition.
OBJECTIVE:
To compare the increase in weight gain among Severe Acute malnourished children taking F-75/
F-100 Formula diet with local Ready-to-use-therapeutic-food.
HYPOTHESIS:

The increase in body weight in Severe acute Malnourished Children on RUTF (local cereal based
food) is comparable to that on F-75 and F-100 Formula diet
OPERATIONAL DEFINITION:
Severe Acute Malnutrition: Severe acute malnutrition (SAM) arises as a consequence of a
sudden period of food shortage and is associated with loss of a person's body fat and wasting of
their skeletal muscle clinically defined by weight for height <3SD.
Ready-to-use-therapeutic-food: Locally prepared food from local recipes other then F-75/
F-100.

MATERIAL AND METHODS


STUDY DESIGN: Randomized Clinical Trial.
SETTING: Pediatrics Ward, Bolan Medical Complex Hospital, Quetta.
DURATION OF STUDY: Seven months after approval of synopsis.
SAMPLE SIZE: The calculated sample size is 192 cases in two groups with 96 cases in group A
and 96 cases in group B with F-75 F-100 formula diet and RUTF respectively. The margin of
error is at 5%, with level of confidence at 95% (confidence interval is 7.05, population
100000(approximate children population of Quetta) and sample size is and percentage is 38%
(malnutrition prevalence in Pakistan).
SAMPLING TECHNIQUE: Non-probability purposive.
SAMPLE SELECTION: From Pediatrics in-patient Department with patients having a clinical

diagnosis of severe primary malnutrition will be selected for the study using following selection
criteria.

SAMPLE SELECTION:
Inclusion Criteria:
1. Children with severe acute malnutrition (weight for length <3SD of WHO reference).
2. Children of both genders shall be included
3. Age: 6 months to 5 years
4. No signs of concurrent infection (e.g. diarrhea, lower respiratory tract infection/
pneumonia, severe anemia, fever, sepsis, electrolyte imbalance, etc.)
Exclusion Criteria:
1. All children with chronic malnutrition/secondary malnutrition shall be excluded.

DATA COLLECTION PROCEDURE:


All patients approaching the Pediatrics department who fulfill the inclusion criteria will be
registered in the study trial. Informed consent will be obtained for inclusion in the study. All the
diet formulation (F-75 F-100 and RUTF) will be made under supervised scrutiny by competent
therapeutic feeding experts. All feed servings will be weighted and dully verified by a
therapeutic feeding expert. Patients will be followed in ward and after discharge for a period of
26 weeks so as to record the weight gain following diet intake.
100 Pa&ents will be included in the study according to inclusion criteria. Patients will be
divided into two groups A and B with 50 patients each by using random table with F-75 formula
diet and RUTF respectively. Data will be collected on a proforma, which will be continually

maintained. All the patient information will be kept highly confidential. All Patients will be
weighted daily. The residual diet would also be measured. The disappearance of edema will be
required day wise.
STATISTICAL ANALYSIS:
All the collected data from the Performa will be entered into SPSS 2. Mean + SD will be
expressed for continuous variable like age, degree of weight gain. Paired two-tailed Student's ttest will be used to compare categorical variables like elimination of edema, loss of irritability,
improvement in appetite etc. A p value of < 0.05 will be considered to be statistically significant.
Data will be presented in frequency tables, bar graphs and pie charts. Any confounding variable
will be controlled by strictly implementing sample selection criteria.

PROFORMA
COMPARISON OF WEIGHT GAIN IN SEVERE PRIMARY
MALNOURISHED CHILDERN TAKING F-75/F-100 FORMULA DIET
VERSUS SUJI.

Hospital Registration Number: ________ Case Number: __________ Group: A B


Patient Name: ___________ Parentage: ______________ Age: _______ Sex: _______
Date of Admission: ________ Contact Number: _________ Date of Discharge: _______
Height: ______ Weight on Admission: ___________ Weight on Discharge: ____________
Address: ____________________________________________________________________
____________________________________________________________________________

F-75/F-100 FORMULA DIET


DATE

AMOUNT

Current
Weight

Weight gain
\day

Total average weight gain on F-75/F-100 =

RUTF DIET
DATE

AMOUNT

Current
Weight

Weight
gain\day

Total average weight gain on RUTF=

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