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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01758159 |
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Date of registration:
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18/12/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effect of CFR and Iron Supplementation on Iron Status and Gut Microbiota of 1-2 Years Old Myanmar Children
CFR |
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Scientific title:
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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 |
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Date of first enrolment:
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February 2013 |
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Target sample size:
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433 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01758159 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Phase:
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Phase 3
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Countries of recruitment
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Myanmar
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Contacts
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Name:
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Lwin Mar Hlaing, M.B.,B.S, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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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 |
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Key inclusion & exclusion criteria
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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
Age minimum:
12 Months
Age maximum:
18 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Iron Deficiency
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Iron Deficiency Anemia
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Intervention(s)
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Other: CFR
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Dietary Supplement: Iron supplementation
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Primary Outcome(s)
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Change in Gut microbiota composition
[Time Frame: Baseline (at week 0), Endline (at week 24)]
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Change in Iron status
[Time Frame: Baseline (at week 0) and Endline (at week 24)]
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Secondary ID(s)
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HHlaing CFR Myanmar
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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