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

NCT01758159 | Unknown Phase 3 DMC

• 1 other identifier: HHlaing CFR Myanmar
• Study Type: interventional
• Target: 433
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Iron Deficiency; Iron Deficiency Anemia

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline (at week 0), Endline (at week 24)

Study Arms (4)

CFR group

EXPERIMENTAL

The children in this group will receive complementary feeding with locally available foods according to optimized complementary feeding recommendation (CFR)

Dietary Supplement: Iron supplementation

Fe group

EXPERIMENTAL

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

CFR + Fe group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

The children in this group will receive basic health services and placebo syrup.

Interventions

Iron supplementation DIETARY_SUPPLEMENT

CFR + Fe group; CFR group

CFR OTHER

Complementary feeding with locally available foods according to optimized complementary feeding recommendation (CFR)

Also known as: Complementary Feeding Recommendation

CFR + Fe group; Fe group

Eligibility Criteria

• Age: 12 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age between 12-18 months
• Apparently healthy
• Not consuming regular iron containing supplements during the last 4 months

You may not qualify if:

• 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

Sponsors & Collaborators

• SEAMEO Regional Centre for Food and Nutrition: lead
• National Nutrition Center, Department of Health, Ministry of Health, Myanmar: collaborator
• National Health Laboratory (Department of Health,Ministry of Health, Myanmar): collaborator

Study Sites (1)

National Nutrition Center, Ministry of Health, Myanmar

Pan Ta Naw Township and Kyaungon Township, Ayeyarwady Region, Burma

Location

Related Publications (12)

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  PMID: 19056658 BACKGROUND

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  PMID: 16920861 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 19472604 BACKGROUND

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  PMID: 9805226 BACKGROUND

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  PMID: 17693180 BACKGROUND

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  PMID: 17158406 BACKGROUND

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  PMID: 21875444 BACKGROUND

MeSH Terms

Conditions

Iron Deficiencies; Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Officer, PhD Candidate (Nutrition)

Study Record Dates

• First Submitted: December 18, 2012
• First Posted: January 1, 2013
• Study Start: February 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: April 1, 2014
• Last Updated: October 1, 2013

Record last verified: 2013-09

Locations

BU (1)