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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