Iron Bioavailability of Fortified Oat Drink
Overview
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.
Full Title of Study: “Iron Bioavailability Study Of Fortified Oat Drink”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Basic Science
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: September 2011
Interventions
- Other: Dietary Intervention (with Vit C then without Vit C)
- Fortified oat drink with vitamin C followed by fortified oat drink without vitamin C
- Other: Dietary Intervention (without Vit C followed by with Vit C)
- Fortified oat drink without vitamin C followed by fortified oat drink with vitamin C
Arms, Groups and Cohorts
- Experimental: Drink with Vit C then drink without Vit C
- Fortified oat drink with vitamin C on day 1 followed by fortified oat drink without vitamin C on day 2
- Experimental: Drink without Vit C then drink with Vit C
- Fortified oat drink without vitamin C on day 1 followed by fortified oat drink with vitamin C on day 2
Clinical Trial Outcome Measures
Primary Measures
- Percent Iron Absorption
- Time Frame: 14 days after administration
- Percentage of iron available for absorption from fortified oat drink with and without added vitamin C
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 6 Years
Maximum Age: 6 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- PepsiCo Global R&D
- Collaborator
- Food and Nutrition Research Institute, Philippines
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Trinidad P Trinidad, PhD, Principal Investigator, FNRI
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