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

Primary Purpose

Iron Deficiency, Iron Deficiency Anemia

Status
Unknown status
Phase
Phase 3
Locations
Myanmar
Study Type
Interventional
Intervention
Iron supplementation
CFR
Sponsored by
SEAMEO Regional Centre for Food and Nutrition
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Iron Deficiency

Eligibility Criteria

12 Months - 18 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • National Nutrition Center, Ministry of Health, Myanmar

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

CFR group

Fe group

CFR + Fe group

Control group

Arm Description

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

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.

The children in this group will receive both local food-based complementary feeding according to CFR and Iron supplementation for 24 weeks duration

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 18, 2012
Last Updated
September 29, 2013
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)
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1. Study Identification

Unique Protocol Identification Number
NCT01758159
Brief Title
Effect of CFR and Iron Supplementation on Iron Status and Gut Microbiota of 1-2 Years Old Myanmar Children
Acronym
CFR
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
April 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency, Iron Deficiency Anemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
433 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CFR group
Arm Type
Experimental
Arm Description
The children in this group will receive complementary feeding with locally available foods according to optimized complementary feeding recommendation (CFR)
Arm Title
Fe group
Arm Type
Experimental
Arm Description
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.
Arm Title
CFR + Fe group
Arm Type
Experimental
Arm Description
The children in this group will receive both local food-based complementary feeding according to CFR and Iron supplementation for 24 weeks duration
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
The children in this group will receive basic health services and placebo syrup.
Intervention Type
Dietary Supplement
Intervention Name(s)
Iron supplementation
Intervention Type
Other
Intervention Name(s)
CFR
Other Intervention Name(s)
Complementary Feeding Recommendation
Intervention Description
Complementary feeding with locally available foods according to optimized complementary feeding recommendation (CFR)
Primary Outcome Measure Information:
Title
Change in Iron status
Description
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)
Title
Change in Gut microbiota composition
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lwin Mar Hlaing, M.B.,B.S, MPH
Organizational Affiliation
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
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Nutrition Center, Ministry of Health, Myanmar
City
Pan Ta Naw Township and Kyaungon Township
State/Province
Ayeyarwady Division
Country
Myanmar

12. IPD Sharing Statement

Citations:
PubMed Identifier
19056658
Citation
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Results Reference
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PubMed Identifier
16920861
Citation
Ferguson EL, Darmon N, Fahmida U, Fitriyanti S, Harper TB, Premachandra IM. Design of optimal food-based complementary feeding recommendations and identification of key "problem nutrients" using goal programming. J Nutr. 2006 Sep;136(9):2399-404. doi: 10.1093/jn/136.9.2399.
Results Reference
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Citation
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.
Results Reference
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PubMed Identifier
19472604
Citation
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.
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PubMed Identifier
9805226
Citation
Gibson RS, Ferguson EL, Lehrfeld J. Complementary foods for infant feeding in developing countries: their nutrient adequacy and improvement. Eur J Clin Nutr. 1998 Oct;52(10):764-70. doi: 10.1038/sj.ejcn.1600645.
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PubMed Identifier
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Citation
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Effect of CFR and Iron Supplementation on Iron Status and Gut Microbiota of 1-2 Years Old Myanmar Children

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