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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT01634932 |
Date of registration:
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03/07/2012 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Iron Absorption From Regular, Biofortified and Post-harvest Fortified Pearl Millet
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Scientific title:
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Comparison of Iron Absorption From Regular-iron, Iron Biofortified, and Post-harvest Iron-fortified Pearl Millet Using Multiple Meals in Young Women |
Date of first enrolment:
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July 2012 |
Target sample size:
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22 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT01634932 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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Phase:
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N/A
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Countries of recruitment
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Benin
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Females of reproductive age, 18-30 years
- Low/marginal iron status (Hb > 9.0 g/dl, SF < 25 ;g/L)
- Maximum body weight 65 kg
- Normal body mass index (18.5-25 kg/m2)
- Obtained consent
Exclusion Criteria:
- Pregnancy or Lactating (assessed by pregnancy test)
- Fever (body temperature >37.5 °C)
- Symptomatic malaria infection (positive blood smear for Plasmodium species +
symptoms)
- Infection with soil-transmitted helminthes (positive stool samples and/or urine
samples)
- Intake of mineral/vitamin supplements 2 weeks before and during the study
- Metabolic or gastrointestinal disorders, eating disorders or food allergy
- Regular intake of medication
- Blood transfusion, blood donation or significant blood loss (accident, surgery) over
the past 6 months
- Currently participating in another clinical trial or having participated in another
clinical trial during the last 3 months prior to the beginning of this study
- Former participation in a study involving administration of iron stable isotopes
- Subject who cannot be expected to comply with study protocol
Age minimum:
18 Years
Age maximum:
30 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Biofortification
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Iron Deficiency
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Intervention(s)
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Other: Regular iron
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Other: Post-harvest iron-fortifed millet
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Other: Iron biofortified millet
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Primary Outcome(s)
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Iron isotope ratio in blood samples
[Time Frame: Study day 33 (32 days after administration of isotopic label in the first test meal/End of the study)]
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Secondary ID(s)
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Fe_Biofortified_Millet
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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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