A Phase 3 interventional study of Iron supplementation and CFR in Iron Deficiency and Iron Deficiency Anemia, sponsored by SEAMEO Regional Centre for Food and Nutrition. Status unknown at 1 site in Myanmar. Open to participants aged 12 Months to 18 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-10-01.
Sponsored by SEAMEO Regional Centre for Food and Nutrition · Phase 3, Interventional, and Prevention
Complementary feeding diet in developing countries cannot meet iron requirements of infants and young children. Iron supplementation is mostly used to treat iron deficiency whereas iron fortification is cost-effective strategy to control iron deficiency in developing countries. However, a recent study showed that iron fortification imposed negative impact on gut microbiota by increasing colonization of gut pathogen over beneficial bacteria. Gut microbiota plays essential roles in nutrient absorption, vitamin synthesis; intestinal mucosal barrier function and pathogen displacement. Iron is essential for growth and virulence of most gut pathogens and so iron supplementation might have similar negative impact on gut microbiota composition. Therefore, nutrition interventions would not be justified by assessing micronutrient status alone ignoring any possible deterioration of gut microbiota. The investigators hypothesized that optimizing the nutrient intake from locally available foods according to complementary feeding recommendation (CFR) can improve the iron status of these children while maintaining healthy gut microbiota composition.
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.
600 studies on the registry are indexed under Anemia, Iron-Deficiency; 95 are open to participants now.
This study's enrollment of 433 is above the median of 100 across 459 interventional studies indexed under Anemia, Iron-Deficiency.
Browse Anemia, Iron-Deficiency studies →SEAMEO Regional Centre for Food and Nutrition is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
Compared within Anemia, Iron-Deficiency, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Iron Deficiencies. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The children in this group will receive complementary feeding with locally available foods according to optimized complementary feeding recommendation (CFR)
Dietary Supplement: Iron supplementation
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.
Other: CFR
The children in this group will receive both local food-based complementary feeding according to CFR and Iron supplementation for 24 weeks duration
Dietary Supplement: Iron supplementation · Other: CFR
The children in this group will receive basic health services and placebo syrup.
Complementary feeding with locally available foods according to optimized complementary feeding recommendation (CFR)
Also known as: Complementary Feeding Recommendation
Change in Iron status
Iron status indicators including hemoglobin (Hb), serum ferritin (SF), soluble transferrin receptor (sTfR) concentration will be measured at the beginning and at the end of 24 weeks intervention.
Time frame: Baseline (at week 0) and Endline (at week 24)
Change in Gut microbiota composition
Sub-samples analysis from 60 children (15 children from each group) will be done to detect the DNA-copy number of Total bacteria, Lactobacillus, Bifidobacteria and Enterobacteria in group and Enteropathogenic E.coli (EPEC), Enterotoxigenic E.coli (ETEC) and Enteroaggregative E.coli (EAEC) species by PCR analysis at the beginning and at the end of 24 weeks intervention.
Time frame: Baseline (at week 0), Endline (at week 24)
The record gives a start of Feb 2013, a primary completion of Aug 2013 and a completion of Apr 2014. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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SEAMEO Regional Centre for Food and Nutrition