Effect of CFR and Iron Supplementation on Iron Status and Gut Microbiota of 1-2 Years Old Myanmar Children
NCT ID: NCT01758159
Last Updated: 2013-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
433 participants
INTERVENTIONAL
2013-02-28
2014-04-30
Brief Summary
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A randomized, placebo-controlled, community-based, intervention trial will be conducted in Ayeyarwady division of Myanmar where childhood undernutrition is prevalent. The aim of this study is to compare the effect of optimized CFR to iron supplementation on iron status and gut microbiota composition of 1-2years old Myanmar children. Cluster randomization will be done at the village level to randomly allocate the villages into CFR or non-CFR villages. Individual randomization will be done to randomly assign each child into iron or placebo syrup so that individual children will receive one of 4 treatment groups (CFR, Fe, CFR + Fe, and Control) for a period of 24 weeks. Based on expected between-groups difference of hemoglobin 5g/L, at 80% power, 5% level of significance, 15% drop-out rate; after taking into account the cluster effect; required sample will be 109 per group (total = 436). A sub-sample of 15 children from each group will be randomly selected for gut microbiota assessment (total = 60). Blood samples for iron status and stool samples for gut microbiota assessment will be collected at baseline and endline. Anthropometric measurements, usual intake of iron and infectious disease morbidity will also be assessed.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
QUADRUPLE
Study Groups
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CFR group
The children in this group will receive complementary feeding with locally available foods according to optimized complementary feeding recommendation (CFR)
Iron supplementation
Fe group
The children in this group will receive iron supplementation 2mg/kg/day of ferric Na EDTA (in the form of syrup) daily for 24 weeks duration.
CFR
Complementary feeding with locally available foods according to optimized complementary feeding recommendation (CFR)
CFR + Fe group
The children in this group will receive both local food-based complementary feeding according to CFR and Iron supplementation for 24 weeks duration
Iron supplementation
CFR
Complementary feeding with locally available foods according to optimized complementary feeding recommendation (CFR)
Control group
The children in this group will receive basic health services and placebo syrup.
No interventions assigned to this group
Interventions
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Iron supplementation
CFR
Complementary feeding with locally available foods according to optimized complementary feeding recommendation (CFR)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Apparently healthy
* Not consuming regular iron containing supplements during the last 4 months
Exclusion Criteria
* Malaria test positive with Immuno-chromatographic test (ICT)
* Mothers/ Caregivers are not willing to join the study
* Suffer from chronic diseases which can affect their dietary intake
12 Months
18 Months
ALL
Yes
Sponsors
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National Nutrition Center, Department of Health, Ministry of Health, Myanmar
UNKNOWN
National Health Laboratory (Department of Health,Ministry of Health, Myanmar)
UNKNOWN
SEAMEO Regional Centre for Food and Nutrition
OTHER
Responsible Party
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Lwin Mar Hlaing
Medical Officer, PhD Candidate (Nutrition)
Principal Investigators
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Lwin Mar Hlaing, M.B.,B.S, MPH
Role: PRINCIPAL_INVESTIGATOR
1. National Nutrition Center, Ministry of Health, Myanmar. 2. South East Asian Ministers of Education Organization - Regional Center for Food and Nutrition (SEAMEO-RECFON), University of Indonesia
Locations
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National Nutrition Center, Ministry of Health, Myanmar
Pan Ta Naw Township and Kyaungon Township, Ayeyarwady Region, Burma
Countries
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References
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Santika O, Fahmida U, Ferguson EL. Development of food-based complementary feeding recommendations for 9- to 11-month-old peri-urban Indonesian infants using linear programming. J Nutr. 2009 Jan;139(1):135-41. doi: 10.3945/jn.108.092270. Epub 2008 Dec 3.
Ferguson EL, Darmon N, Fahmida U, Fitriyanti S, Harper TB, Premachandra IM. Design of optimal food-based complementary feeding recommendations and identification of key "problem nutrients" using goal programming. J Nutr. 2006 Sep;136(9):2399-404. doi: 10.1093/jn/136.9.2399.
Fahmida U, Preedy VR. Food-Based Complementary Feeding and Its Impact on Growth: Southeast Asian Perspectives, Handbook of Growth and Growth Monitoring in Health and Disease. Springer New York; 2012. p. 1599-610.
Gibson RS, Anderson VP. A review of interventions based on dietary diversification or modification strategies with the potential to enhance intakes of total and absorbable zinc. Food Nutr Bull. 2009 Mar;30(1 Suppl):S108-43. doi: 10.1177/15648265090301S107.
Gibson RS, Ferguson EL, Lehrfeld J. Complementary foods for infant feeding in developing countries: their nutrient adequacy and improvement. Eur J Clin Nutr. 1998 Oct;52(10):764-70. doi: 10.1038/sj.ejcn.1600645.
Zimmermann MB, Hurrell RF. Nutritional iron deficiency. Lancet. 2007 Aug 11;370(9586):511-20. doi: 10.1016/S0140-6736(07)61235-5.
Iannotti LL, Tielsch JM, Black MM, Black RE. Iron supplementation in early childhood: health benefits and risks. Am J Clin Nutr. 2006 Dec;84(6):1261-76. doi: 10.1093/ajcn/84.6.1261.
World Health Organization. Conclusions and recommendations of the WHO Consultation on prevention and control of iron deficiency in infants and young children in malaria-endemic areas. Food Nutr Bull. 2007 Dec;28(4 Suppl):S621-7. doi: 10.1177/15648265070284s414. No abstract available.
Prakash S, Rodes L, Coussa-Charley M, Tomaro-Duchesneau C. Gut microbiota: next frontier in understanding human health and development of biotherapeutics. Biologics. 2011;5:71-86. doi: 10.2147/BTT.S19099. Epub 2011 Jul 11.
Zimmermann MB, Chassard C, Rohner F, N'goran EK, Nindjin C, Dostal A, Utzinger J, Ghattas H, Lacroix C, Hurrell RF. The effects of iron fortification on the gut microbiota in African children: a randomized controlled trial in Cote d'Ivoire. Am J Clin Nutr. 2010 Dec;92(6):1406-15. doi: 10.3945/ajcn.110.004564. Epub 2010 Oct 20.
Monira S, Nakamura S, Gotoh K, Izutsu K, Watanabe H, Alam NH, Endtz HP, Cravioto A, Ali SI, Nakaya T, Horii T, Iida T, Alam M. Gut microbiota of healthy and malnourished children in bangladesh. Front Microbiol. 2011 Nov 21;2:228. doi: 10.3389/fmicb.2011.00228. eCollection 2011.
Yap GC, Chee KK, Hong PY, Lay C, Satria CD, Sumadiono, Soenarto Y, Haksari EL, Aw M, Shek LP, Chua KY, Zhao Y, Leow D, Lee BW. Evaluation of stool microbiota signatures in two cohorts of Asian (Singapore and Indonesia) newborns at risk of atopy. BMC Microbiol. 2011 Aug 26;11:193. doi: 10.1186/1471-2180-11-193.
Other Identifiers
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HHlaing CFR Myanmar
Identifier Type: -
Identifier Source: org_study_id