This trial is active, not recruiting.

Conditions iron deficiency, iron deficiency anemia
Treatments iron supplementation, cfr
Phase phase 3
Sponsor SEAMEO Regional Centre for Food and Nutrition
Collaborator National Nutrition Center, Department of Health, Ministry of Health, Myanmar
Start date February 2013
End date August 2013
Trial size 433 participants
Trial identifier NCT01758159, HHlaing CFR Myanmar


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
The children in this group will receive complementary feeding with locally available foods according to optimized complementary feeding recommendation (CFR)
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.
cfr Complementary Feeding Recommendation
Complementary feeding with locally available foods according to optimized complementary feeding recommendation (CFR)
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 Recommendation
Complementary feeding with locally available foods according to optimized complementary feeding recommendation (CFR)
(Placebo Comparator)
The children in this group will receive basic health services and placebo syrup.

Primary Outcomes

Change in Iron status
time frame: Baseline (at week 0) and Endline (at week 24)
Change in Gut microbiota composition
time frame: Baseline (at week 0), Endline (at week 24)

Eligibility Criteria

Male or female participants from 12 months up to 18 months old.

Inclusion Criteria: - Age between 12-18 months - Apparently healthy - Not consuming regular iron containing supplements during the last 4 months Exclusion Criteria: - With severe anemia (Hemoglobin < 50g/L) - 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

Additional Information

Official title The Effect of Optimized Local Food-based Complementary Feeding With or Without Iron Supplementation on Iron Status and Gut Microbiota of 1-2 Years Old Myanmar Children
Principal investigator Lwin Mar Hlaing, M.B.,B.S, MPH
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by SEAMEO Regional Centre for Food and Nutrition.