Iron Bioavailability of Fortified Oat Drink

PepsiCo Global R&D21 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Iron Absorption

Interventions

Dietary Intervention (with Vit C then without Vit C)OTHER

Fortified oat drink with vitamin C followed by fortified oat drink without vitamin C

Dietary Intervention (without Vit C followed by with Vit C)OTHER

Fortified oat drink without vitamin C followed by fortified oat drink with vitamin C

Eligibility

Sex: ALLMin age: 6 YearsMax age: 6 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Food and Nutrition Research Institute

City of Taguig, Philippines

Outcomes

Primary Outcomes

Percent Iron Absorption

Percentage of iron available for absorption from fortified oat drink with and without added vitamin C

Time frame: 14 days after administration

Data from ClinicalTrials.gov

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