Phase 4
Completed N=20
Iron Bioavailability of Fortified Oat Drink
Iron Absorption
Source: ClinicalTrials.gov NCT01423162 ↗
Enrolled (actual)
20
Serious AEs
—
Results posted
Sep 2012
Primary outcomePrimary: Percent Iron Absorption — 7.14; 5.65 percentage of Iron absorbed
Summary
This study will follow a double blinded randomized controlled study design to enroll 20 apparently healthy 6 year old children. The children will be fed with two different nutrient fortified oat drinks labeled with stable isotopes of iron (Fe-57 or Fe-58 as NaFeEDTA). Fourteen days after consumption of meals on Day 2, blood will be drawn from the children for stable isotope measurements and iron absorption will be calculated.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Iron Absorption |
7.14; 5.65 | — |
Eligibility Criteria
Inclusion Criteria
- 6 year old children (inclusive)
- Normal BMI for age (WHO standard: 15.3-15.5 kg)
- Apparently healthy, no metabolic or gastrointestinal disorder; non-anemic (Hemoglobin values not less than 11.5 mg/dL -WHO cut-off for respective age)
- No medication or vitamin/mineral supplement will be consumed during the study; intake of vitamin/mineral supplement will be discontinued 2 weeks before the start of the study
- Parents demonstrate an understanding of the given information and ability to comply with the study procedure
- Obtained parental or legal representative's informed consent
Exclusion Criteria
- Known gastrointestinal or metabolic disorder or experiencing blood losses over the past 6 months;
- Children taking medication
- Children who are anemic (Hemoglobin values less than 11.5 mg/dL - WHO cut-off value for this age)
- Currently participating or having participated in another clinical trial during the past 3 months prior to the beginning of the study
Data sourced from ClinicalTrials.gov (NCT01423162). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.