Iron DeficiencyPhase 3CFRNCT01758159
Effect of CFR and Iron Supplementation on Iron Status and Gut Microbiota of 1-2 Years Old Myanmar Children
A Phase 3 study testing Iron supplementation and CFR in people with Iron Deficiency and Iron Deficiency Anemia, run by SEAMEO Regional Centre for Food and Nutrition at 1 site in Burma.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency, Iron Deficiency Anemia
- What is being tested?
- Iron supplementation and CFR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 433 participants
- Where
- 1 siteBurma
- Study dates
- Feb 2013to Apr 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age between 12-18 months
- Apparently healthy
- Not consuming regular iron containing supplements during the last 4 months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Burma1 site
National Nutrition Center, Ministry of Health, Myanmar
Pan Ta Naw Township and Kyaungon Township, Ayeyarwady
About this study
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
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
- Being tested
- Iron supplementation, CFR
- Medical subject headings
- Iron Deficiencies, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron supplementationDietary supplement
CFROther
Also called Complementary Feeding Recommendation
Complementary feeding with locally available foods according to optimized complementary feeding recommendation (CFR)
| Study group | Role | What they receive |
|---|---|---|
| CFR group | Experimental | The children in this group will receive complementary feeding with locally available foods according to optimized complementary feeding recommendation (CFR) Receives: 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. Receives: 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 Receives: Dietary Supplement: Iron supplementation; Other: CFR |
| Control group | Placebo comparator | The children in this group will receive basic health services and placebo syrup. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (at week 0), Endline (at week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionAug 2013
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Iron DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 433 participants (actual)
Sponsor and investigators
- Lead sponsor
- SEAMEO Regional Centre for Food and Nutrition
- Sponsor type
- University, hospital or other
- Collaborators
- National Nutrition Center, Department of Health, Ministry of Health, Myanmar, National Health Laboratory (Department of Health,Ministry of Health, Myanmar)
- Responsible party
- Principal investigator, Lwin Mar Hlaing, SEAMEO Regional Centre for Food and Nutrition
- Investigators
- Lwin Mar Hlaing, M.B.,B.S, MPH, Principal investigator, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758159
- Sponsor's protocol ID
- HHlaing CFR Myanmar
- Acronym
- CFR
- Status last verified
- Sep 2013
- First submitted
- 18 Dec 2012
- Last updated
- 1 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Santika O, Fahmida U, Ferguson EL. Development of food-based complementary feeding recommendations for 9- to 11-month-old peri-urban Indonesian infants using linear programming. J Nutr. 2009 Jan;139(1):135-41. doi: 10.3945/jn.108.092270. Epub 2008 Dec 3.
PubMed 19056658Ferguson 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.
PubMed 16920861Fahmida 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.
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.
PubMed 19472604Gibson 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.
PubMed 9805226Zimmermann MB, Hurrell RF. Nutritional iron deficiency. Lancet. 2007 Aug 11;370(9586):511-20. doi: 10.1016/S0140-6736(07)61235-5.
PubMed 17693180Iannotti LL, Tielsch JM, Black MM, Black RE. Iron supplementation in early childhood: health benefits and risks. Am J Clin Nutr. 2006 Dec;84(6):1261-76. doi: 10.1093/ajcn/84.6.1261.
PubMed 17158406World Health Organization. Conclusions and recommendations of the WHO Consultation on prevention and control of iron deficiency in infants and young children in malaria-endemic areas. Food Nutr Bull. 2007 Dec;28(4 Suppl):S621-7. doi: 10.1177/15648265070284s414. No abstract available.
PubMed 18297899Prakash S, Rodes L, Coussa-Charley M, Tomaro-Duchesneau C. Gut microbiota: next frontier in understanding human health and development of biotherapeutics. Biologics. 2011;5:71-86. doi: 10.2147/BTT.S19099. Epub 2011 Jul 11.
PubMed 21847343Zimmermann MB, Chassard C, Rohner F, N'goran EK, Nindjin C, Dostal A, Utzinger J, Ghattas H, Lacroix C, Hurrell RF. The effects of iron fortification on the gut microbiota in African children: a randomized controlled trial in Cote d'Ivoire. Am J Clin Nutr. 2010 Dec;92(6):1406-15. doi: 10.3945/ajcn.110.004564. Epub 2010 Oct 20.
PubMed 20962160Monira S, Nakamura S, Gotoh K, Izutsu K, Watanabe H, Alam NH, Endtz HP, Cravioto A, Ali SI, Nakaya T, Horii T, Iida T, Alam M. Gut microbiota of healthy and malnourished children in bangladesh. Front Microbiol. 2011 Nov 21;2:228. doi: 10.3389/fmicb.2011.00228. eCollection 2011.
PubMed 22125551Yap GC, Chee KK, Hong PY, Lay C, Satria CD, Sumadiono, Soenarto Y, Haksari EL, Aw M, Shek LP, Chua KY, Zhao Y, Leow D, Lee BW. Evaluation of stool microbiota signatures in two cohorts of Asian (Singapore and Indonesia) newborns at risk of atopy. BMC Microbiol. 2011 Aug 26;11:193. doi: 10.1186/1471-2180-11-193.
PubMed 21875444Hlaing LM, Htet MK, Gibson R, Utomo B, Firmansyah A, Fahmida U. Is iron supplementation likely to impair linear growth and gut microbiota composition of Myanmar young children when complementary feeding is not optimized? A randomized controlled trial. Philos Trans R Soc Lond B Biol Sci. 2026 May 14;381(1950):20250042. doi: 10.1098/rstb.2025.0042.
PubMed 42132028
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01758159
- Acronym / sponsor ID
- CFR / HHlaing CFR Myanmar
- Conditions
- Iron Deficiency, Iron Deficiency Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 433 participants (actual)
- Lead sponsor
- SEAMEO Regional Centre for Food and NutritionUniversity, hospital or other
- Collaborators
- National Nutrition Center, Department of Health, Ministry of Health, Myanmar, National Health Laboratory (Department of Health,Ministry of Health, Myanmar)
- Study start
- Feb 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Apr 2014 (estimated)
- First posted
- 1 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CFR group | Experimental | Dietary Supplement: Iron supplementationThe children in this group will receive complementary feeding with locally available foods according to optimized complementary feeding recommendation (CFR) |
| Fe group | Experimental | Other: CFRThe 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 + Fe group | Experimental | Dietary Supplement: Iron supplementation, Other: CFRThe children in this group will receive both local food-based complementary feeding according to CFR and Iron supplementation for 24 weeks duration |
| Control group | Placebo comparator | –The children in this group will receive basic health services and placebo syrup. |
Who may qualify
- Ages
- 12 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age between 12-18 months
- Apparently healthy
- Not consuming regular iron containing supplements during the last 4 months
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iron supplementation | Dietary supplement | CFR + Fe group, CFR group |
| CFRAlso: Complementary Feeding RecommendationComplementary feeding with locally available foods according to optimized complementary feeding recommendation (CFR) | Other | CFR + Fe group, Fe group |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2013.
- Background: PubMed 19056658Santika O, Fahmida U, Ferguson EL. Development of food-based complementary feeding recommendations for 9- to 11-month-old peri-urban Indonesian infants using linear programming. J Nutr. 2009 Jan;139(1):135-41. doi: 10.3945/jn.108.092270. Epub 2008 Dec 3.
- Background: PubMed 16920861Ferguson 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.
- BackgroundFahmida 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: PubMed 19472604Gibson 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.
- Background: PubMed 9805226Gibson 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.
- Background: PubMed 17693180Zimmermann MB, Hurrell RF. Nutritional iron deficiency. Lancet. 2007 Aug 11;370(9586):511-20. doi: 10.1016/S0140-6736(07)61235-5.
- Background: PubMed 17158406Iannotti LL, Tielsch JM, Black MM, Black RE. Iron supplementation in early childhood: health benefits and risks. Am J Clin Nutr. 2006 Dec;84(6):1261-76. doi: 10.1093/ajcn/84.6.1261.
- Background: PubMed 18297899World Health Organization. Conclusions and recommendations of the WHO Consultation on prevention and control of iron deficiency in infants and young children in malaria-endemic areas. Food Nutr Bull. 2007 Dec;28(4 Suppl):S621-7. doi: 10.1177/15648265070284s414. No abstract available.
- Background: PubMed 21847343Prakash S, Rodes L, Coussa-Charley M, Tomaro-Duchesneau C. Gut microbiota: next frontier in understanding human health and development of biotherapeutics. Biologics. 2011;5:71-86. doi: 10.2147/BTT.S19099. Epub 2011 Jul 11.
- Background: PubMed 20962160Zimmermann MB, Chassard C, Rohner F, N'goran EK, Nindjin C, Dostal A, Utzinger J, Ghattas H, Lacroix C, Hurrell RF. The effects of iron fortification on the gut microbiota in African children: a randomized controlled trial in Cote d'Ivoire. Am J Clin Nutr. 2010 Dec;92(6):1406-15. doi: 10.3945/ajcn.110.004564. Epub 2010 Oct 20.
- Background: PubMed 22125551Monira S, Nakamura S, Gotoh K, Izutsu K, Watanabe H, Alam NH, Endtz HP, Cravioto A, Ali SI, Nakaya T, Horii T, Iida T, Alam M. Gut microbiota of healthy and malnourished children in bangladesh. Front Microbiol. 2011 Nov 21;2:228. doi: 10.3389/fmicb.2011.00228. eCollection 2011.
- Background: PubMed 21875444Yap GC, Chee KK, Hong PY, Lay C, Satria CD, Sumadiono, Soenarto Y, Haksari EL, Aw M, Shek LP, Chua KY, Zhao Y, Leow D, Lee BW. Evaluation of stool microbiota signatures in two cohorts of Asian (Singapore and Indonesia) newborns at risk of atopy. BMC Microbiol. 2011 Aug 26;11:193. doi: 10.1186/1471-2180-11-193.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lwin Mar Hlaing, M.B.,B.S, MPH principal investigator
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Iron supplementation and CFR in people with Iron Deficiency and Iron Deficiency Anemia, run by SEAMEO Regional Centre for Food and Nutrition at 1 site in Burma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burma. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Iron status (time frame: Baseline (at week 0) and Endline (at week 24)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01758159, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2013.