Iron Bioavailability of Fortified Oat Drink

Phase 4

Completed

• Conditions: Iron Absorption
• Interventions: Other: Dietary Intervention (with Vit C then without Vit C); Other: Dietary Intervention (without Vit C followed by with Vit C)

• Registration Number: NCT01423162
• Lead Sponsor: PepsiCo Global R&D

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-23
• Study First Submitted QC: 2011-08-24
• Study First Posted: 2011-08-25
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-08
• Results First Submitted: 2012-08-22
• Results First Submitted QC: 2012-08-22
• Last Update Submitted: 2012-08-22
• Results First Posted: 2012-09-21
• Last Update Posted: 2012-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Drink with Vit C then drink without Vit C	Dietary Intervention (with Vit C then without Vit C)	Fortified oat drink with vitamin C on day 1 followed by fortified oat drink without vitamin C on day 2
Drink without Vit C then drink with Vit C	Dietary Intervention (without Vit C followed by with Vit C)	Fortified oat drink without vitamin C on day 1 followed by fortified oat drink with vitamin C on day 2

Primary Outcome Measures

Name	Time	Method
Percent Iron Absorption	14 days after administration	Percentage of iron available for absorption from fortified oat drink with and without added vitamin C

Trial Locations

Locations (1)

Food and Nutrition Research Institute; 🇵🇭 Taguig City, Philippines