CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 21 enrolled
Drug / intervention
Dietary Intervention (with Vit C then without Vit C) +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01423162
NCT01423162Phase 4Completed

Iron Bioavailability Study Of Fortified Oat Drink

PepsiCo Global R&D·interventional·Posted Aug 25, 2011·Updated Sep 21, 2012

In Brief

A Phase 4 clinical trial evaluating Dietary Intervention (with Vit C then without Vit C) and Dietary Intervention (without Vit C followed by with Vit C) for Iron Absorption. Completed, enrolled 21 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIron Absorption
CountriesPhilippines

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 25, 2011
Enrollment StartAug 1, 2011
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 14.9 years ago

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