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

September 29, 2013 updated by: Lwin Mar Hlaing, SEAMEO Regional Centre for Food and Nutrition

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

433

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Myanmar
    • Ayeyarwady Division
      • Pan Ta Naw Township and Kyaungon Township, Ayeyarwady Division, Myanmar
        • National Nutrition Center, Ministry of Health, Myanmar

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Complementary Feeding Recommendation
PLACEBO_COMPARATOR: Control group
The children in this group will receive basic health services and placebo syrup.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Iron status
Time Frame: Baseline (at week 0) and Endline (at week 24)
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.
Baseline (at week 0) and Endline (at week 24)
Change in Gut microbiota composition
Time Frame: Baseline (at week 0), Endline (at week 24)
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.
Baseline (at week 0), Endline (at week 24)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SEAMEO Regional Centre for Food and Nutrition

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ACTUAL)

August 1, 2013

Study Completion (ANTICIPATED)

April 1, 2014

Study Registration Dates

First Submitted

December 18, 2012

First Submitted That Met QC Criteria

December 25, 2012

First Posted (ESTIMATE)

January 1, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 1, 2013

Last Update Submitted That Met QC Criteria

September 29, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HHlaing CFR Myanmar

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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