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Please note that the project can not commence unless an appropriate work-based supervisor is in place.
There are substantial ethical implications of the proposed project and appropriate ethical approval must be sought
before commencing the research.
Costings and Health & Safety issues have not been adequately addressed.
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School of Biomedical Sciences
3. DECLARATIONS
I confirm that.
all risks and procedural implications have been considered.
the project will be conducted at all times in compliance with the research description/protocol
and in accordance with Governance requirements on recording and reporting.
this application has not been submitted to and rejected by another committee.
Print Name
Sign
Date
Declaration by Student
"I declare this is all my own work and does not contain unreferenced material copied from any
other source. If it is shown that any material has been plagiarised, I understand that a mark of zero
may be awarded and the reason for that mark recorded on my student record."
Print Name
Sign
Date 20/02/2021
4. PROJECT DETAILS
4. PROJECT DETAILS
Lay
summary
word count 147
=
The study aimed to compare various analytes to explore measure for iron
status among paediatrics. According to Sypes et al. (2019) of 187
countries, the global prevalence of anaemia was 33% in 2010. An iron
deficiency with the greatest burden on children under five and women was
the leading cause of anaemia. Biochemical iron status assessments rely on
serum-based indicators such serum ferritin (SF), transferrin saturation and
the soluble transferrin receptor (sTfR). These indicators present challenges
for clinical practise and national nutritional surveys, which are often based
Abstract on the combination of several indicators for the iron status interpretation.
word count Blood samples will be taken in lavender EDTA tubes and serum separator tubes
= 202 by research assistants integrated in primary care practises who are skilled
phlebotomists (Ratcliffe et al., 2016). Data will be analysed using
conventional guidelines and relevant statistical methods based on sample
size and analyte distribution for our primary purpose. Outliers were
removed, and data was categorized gender-wise. As interpretation of iron
level and iron related could be a hectic task and could only be understood
through several testing such as sTfR provide sufficient data to differentiate
between iron deficiency anaemia and anaemia due to chronic diseases but
lacks standardization and cut-off values.
5. PROPOSED INVESTIGATION
To include background, hypothesis, project aims, proposed methods (including statistical
approaches and power calculation), a project timeline (e.g., Gantt chart) and references. Expand
this section as necessary to include all required information. Take note of individual word counts
specified throughout.
The interest in determining iron status was developed more easily in the early 2000s
(Parkin et al., 2016). Assessments for certain of the ferritin model's indicators were labour
demanding and no longer frequently utilised, and finding laboratories willing to continue to
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Various techniques, known to estimate iron level in blood Serum in the blood of
paediatrics in the UK context. The total body iron stores (TBI) model, in which the log
ratio of sTfR to SF is assessed, has been used more recently in paediatrics to assess iron
status. The combined concentrations of sTfR and SF span the entire range of iron status. It
is hypothesised that TBI is a continuous measure that can be used to predict the absence of
bone marrow iron better than SF concentration alone. For additional advancements in iron
status assessment, more thought should be given to methodology, indicator interpretation,
and analytic standardisation.
The study aims to evaluate the efficiency and comparability of the most common
laboratory methods used to detect iron deficiency, depletion or overload in serum or
plasma ferritin concentration in the context of UK.
Various Analytes to Measure Iron Status in Paediatrics
Biochemical assessment of iron status relies primarily on serum-based markers. To
determine the method, which is the most appropriate researcher will utilise a gold-
standard reference method to make comparisons (Raiten et al., 2011). The various
analytes that the study will use for iron status determination are:
● Haemoglobin.
● Serum Ferritin.
● Transferrin saturation.
● Soluble transferrin receptor (sTfR).
● Erythrocyte protoporphyrin.
OBJECTIVES
1. The study aims to explore the best indicator to measure the iron level in paediatrics
aged 0 to 16 years of age.
2. The study will also explore whether target sample suffer from iron deficiency or not.
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Through Haemoglobin:
This procedure will be used to measure haemoglobin adducts of acrylamide and its
primary metabolite glycidamide in human whole blood or erythrocytes.
Specifically, the reaction products with the N terminal valine of the haemoglobin
protein chains (N- [2- carbamoylethyl] valine and N-[2-hydroxycarbamoyl-ethyl]
valine for acrylamide and glycidamide adducts, respectively) will be measured.
Serum iron is bound to transferrin, but only about one third of the iron binding
sites are saturated with iron. The unsaturated iron-binding capacity of transferrin
(UIBC) denotes the available iron-binding sites of serum. The amount of iron that
serum transferrin can bind when completely saturated with an excess of Fe+3 is
the total iron-binding capacity (TIBC). The method1,2 measures the TIBC by first
saturating the transferrin with excess of Fe+3. The remaining iron is adsorbed with
magnesium carbonate, and once the binding process is complete the quelator is
removed by centrifugation, and an assay for iron content performed in the
supernatant. From this measurement the TIBC value is obtained.
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Porphyrins and heme components will be extracted from whole blood into a 4:1
mixture of ethyl acetate-acetic acid. Porphyrins are then separated from heme by
back-extraction into a 1.5 M hydrochloric acid solution, and quantitatively
determined by molecular fluorometry using a spectrofluorometer calibrated with
protoporphyrin IX (PPIX) standard solutions.
Sample:
Blood samples will be taken in lavender EDTA tubes and serum separator tubes by
research assistants integrated in primary care practises who are skilled
phlebotomists. At the practise sites, blood samples will be refrigerated and sent to
the laboratory the same day.
for iron level testing. ANOVA will be used to investigate the effect of age
on Iron status among children, as it is helpful for testing three or more
variables, and it is results also contain fewer type 1 error. Therefore, we’ll
compare our means through ANOVA as well, analysis through these two
statistical models will provide a very comprehend, detailed result, and so
the study will be successful in determining the most potent biomarker for
iron testing.
Project timeline (weekly schedule showing all aspects of the work e.g., literature reviews,
instrument training, experiments, preparation of assessments e.g., as a Gantt chart)
The literature review will be completed within a time frame of 2 weeks. While data
collection will be completed within 10 weeks. Finally, results and analysis will be done
within two weeks.
6. ETHICS
Please discuss these requirements with your Supervisor(s) before completing this section.
All students are required to complete and submit a Biomedical Sciences Research Ethics Filter
Committee pre-screening form and obtain approval from the Committee before you can commence
your research. You will find the form and guidelines for completion within the Research Proposal
folder on Blackboard. Please complete and submit the form via the Ethics Management System by
29 November in order to receive this feedback ASAP and to help you complete the next section.
th
Ethical approval
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under review:
7. OTHER CONSIDERATIONS
Costings*
Please list the itemised costs of consumables & materials required for this project.
Add additional rows as required
DESCRIPTION COST, £
TOTAL COST £
Are the results of this research likely to have operational or commercial potential?
☐ Yes ☐ No
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Indicate briefly why the The research will provide the best biomarker for iron level
research outcomes may estimation and could speed up the process for further
have operational or assessments. The procedure for iron estimation then, will be
commercial potential less time consuming, less hectic and less labouring.
Indicate the Risks and COSHH directly associated with this project.
Overall, there is no significant factor that is associated with this research, only blood
collection will have to be carried out properly.
7. Subjects:
a. How many subjects will be recruited to the study (by group if appropriate)?
N/A
b. Will any of the subjects be from the following vulnerable groups -
YES NO
Children under 16 X
If YES to any of the above, please specify and justify their inclusion.
N/A
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School of Biomedical Sciences
References
References:
Aladhadhi, A.M., Alqahtani, K.M., Etaiwi, S.T., Bajafar, A.A., Nono, A.F., Aldrees, S.E., Almutawa, S.M.
and Alghraibi, S.A., 2018. Pediatrics Iron deficiency anemia from diagnosis to treatment. The Egyptian
Journal of Hospital Medicine, 73(8), pp.7268-7273.
Baker, R.D., and Greer, F.R., 2010. Diagnosis and prevention of iron deficiency and iron-deficiency
anaemia in infants and young children (0–3 years of age). Paediatrics, 126(5), pp.1040-1050.
Berlin, T., Meyer, A., Rotman-Pikielny, P., Natur, A., and Levy, Y., 2011. Soluble transferrin receptor as a
diagnostic laboratory test for the detection of iron deficiency anaemia in the acute illness of hospitalized
patients. The Israel Medical Association journal: IMAJ, 13(2), pp.96-98
Cox, K.A., Parkin, P.C., Anderson, L.N., Chen, Y., Birken, C.S., Maguire, J.L., Macarthur, C., Borkhoff,
C.M., Abdullah, K., Bayoumi, I. and Carsley, S., 2016. Association between meat and meat-alternative
consumption and iron stores in early childhood. Academic pediatrics, 16(8), pp.783-791.
Donker, A.E., Raymakers, R.A., Vlasveld, L.T., van Barneveld, T., Terink, R., Dors, N., Brons, P.P.,
Knoers, N.V. and Swinkels, D.W., 2014. Practice guidelines for the diagnosis and management of
microcytic anemias due to genetic disorders of iron metabolism or heme synthesis. Blood, The Journal of
the American Society of Hematology, 123(25), pp.3873-3886.
Georgieff, M.K., 2017. Iron assessment to protect the developing brain. The American Journal of Clinical
Nutrition, 106(suppl_6), pp.1588S-1593S.
Girelli, D., Nemeth, E. and Swinkels, D.W., 2016. Hepcidin in the diagnosis of iron disorders. Blood,
127(23), pp.2809-2813.
Hershko C. Assessment of iron deficiency. Haematologica. 2018 Dec;103(12):1939-1942. doi:
10.3324/haematol.2018.205575. Epub 2018 Nov 30. PMID: 31013471; PMCID: PMC6269318.
Ito, S., Ikuta, K., Kato, D., Shibusa, K., Niizeki, N., Tanaka, H., Addo, L., Toki, Y., Hatayama, M.,
Inamura, J. and Shindo, M., 2014. Non-transferrin-bound iron assay system utilizing a conventional
automated analyzer. Clinica Chimica Acta, 437, pp.129-135.
Oatley, H., Borkhoff, C.M., Chen, S., Macarthur, C., Persaud, N., Birken, C.S., Maguire, J.L., Parkin, P.C.
and TARGet Kids! Collaboration, 2018. Screening for iron deficiency in early childhood using serum
ferritin in the primary care setting. Pediatrics, 142(6).
Özdemir, N., 2015. Iron deficiency anemia from diagnosis to treatment in children. Turkish Archives of
Pediatrics/Türk Pediatri Arşivi, 50(1), p.11.
Parkin, P.C., DeGroot, J., Maguire, J.L., Birken, C.S. and Zlotkin, S., 2016. Severe iron-deficiency
anaemia and feeding practices in young children. Public health nutrition, 19(4), pp.716-722.
Parkin, P.C., Hamid, J., Borkhoff, C.M., Abdullah, K., Atenafu, E.G., Birken, C.S., Maguire, J.L., Azad,
A., Higgins, V. and Adeli, K., 2017. Laboratory reference intervals in the assessment of iron status in
young children. BMJ paediatrics open, 1(1).
Piva, E., Brugnara, C., Spolaore, F. and Plebani, M., 2015. Clinical utility of reticulocyte parameters.
Clinics in Laboratory medicine, 35(1), pp.133-163.
Raiten, D.J., Namasté, S., Brabin, B., Combs Jr, G., L'Abbe, M.R., Wasantwisut, E. and Darnton-Hill, I.,
2011. Executive summary—biomarkers of nutrition for development: building a consensus. The American
journal of clinical nutrition, 94(2), pp.633S-650S.
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Ratcliffe, L.E., Thomas, W., Glen, J., Padhi, S., Pordes, B.A., Wonderling, D., Connell,
R., Stephens, S., Mikhail, A.I., Fogarty, D.G. and Cooper, J.K., 2016. Diagnosis and management of iron
deficiency in CKD: a summary of the NICE guideline recommendations and their rationale. American
Journal of Kidney Diseases, 67(4), pp.548-558.
Sypes, E.E., Parkin, P.C., Birken, C.S., Carsley, S., MacArthur, C., Maguire, J.L., Borkhoff, C.M.,
Aglipay, M., Anderson, L.N., Dai, D.W. and Keown-Stoneman, C., 2019. Higher body mass index is
associated with iron deficiency in children 1 to 3 years of age. The Journal of pediatrics, 207, pp.198-204.
Van Rheenen, P., 2013. Less iron deficiency anaemia after delayed cord-clamping. Paediatrics and
international child health, 33(2), p.57.
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