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Effect of CFR and Iron Supplementation on Iron Status and Gut Microbiota of 1-2 Years Old Myanmar Children

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Nutrition Center, Department of Health, Ministry of Health, Myanmar
National Health Laboratory (Department of Health,Ministry of Health, Myanmar)
Information provided by (Responsible Party):
Lwin Mar Hlaing, SEAMEO Regional Centre for Food and Nutrition
ClinicalTrials.gov Identifier:
NCT01758159
First received: December 18, 2012
Last updated: September 29, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Iron Deficiency
Iron Deficiency Anemia
Dietary Supplement: Iron supplementation
Other: CFR
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by SEAMEO Regional Centre for Food and Nutrition:

Primary Outcome Measures:
  • Change in Iron status [ Time Frame: Baseline (at week 0) and Endline (at week 24) ] [ Designated as safety issue: No ]
    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.

  • Change in Gut microbiota composition [ Time Frame: Baseline (at week 0), Endline (at week 24) ] [ Designated as safety issue: No ]
    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.


Enrollment: 433
Study Start Date: February 2013
Estimated Study Completion Date: April 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CFR group
The children in this group will receive complementary feeding with locally available foods according to optimized complementary feeding recommendation (CFR)
Dietary Supplement: Iron supplementation
Experimental: 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.
Other: CFR
Complementary feeding with locally available foods according to optimized complementary feeding recommendation (CFR)
Other Name: Complementary Feeding Recommendation
Experimental: 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
Dietary Supplement: Iron supplementation Other: CFR
Complementary feeding with locally available foods according to optimized complementary feeding recommendation (CFR)
Other Name: Complementary Feeding Recommendation
Placebo Comparator: Control group
The children in this group will receive basic health services and placebo syrup.

  Eligibility

Ages Eligible for Study:   12 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01758159

Locations
Myanmar
National Nutrition Center, Ministry of Health, Myanmar
Pan Ta Naw Township and Kyaungon Township, Ayeyarwady Division, Myanmar
Sponsors and Collaborators
SEAMEO Regional Centre for Food and Nutrition
National Nutrition Center, Department of Health, Ministry of Health, Myanmar
National Health Laboratory (Department of Health,Ministry of Health, Myanmar)
Investigators
Principal Investigator: Lwin Mar Hlaing, M.B.,B.S, MPH 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
  More Information

Publications:
Zimmermann MB, Chassard C, Rohner F, N'Goran EK, Nindjin C, Dostal A, et al. The effects of iron fortification on the gut microbiota in African children: a randomized controlled trial in Cô te d'Ivoire. The American Journal of Clinical Nutrition. 2010 December 1, 2010;92(6):1406-15.

Responsible Party: Lwin Mar Hlaing, Medical Officer, PhD Candidate (Nutrition), SEAMEO Regional Centre for Food and Nutrition
ClinicalTrials.gov Identifier: NCT01758159     History of Changes
Other Study ID Numbers: HHlaing CFR Myanmar
Study First Received: December 18, 2012
Last Updated: September 29, 2013
Health Authority: The Ethical Review Committee, Department of Health, Ministry of Health: Myanmar

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia
Anemia, Hypochromic
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Trace Elements

ClinicalTrials.gov processed this record on November 25, 2014