Iron Bioavailability of Fortified Oat Drink

August 22, 2012 updated by: PepsiCo Global R&D

Iron Bioavailability Study Of Fortified Oat Drink

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Philippines
      • Taguig City, Philippines
        • Food and Nutrition Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 6 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Other: Dietary Intervention (with Vit C then without Vit C)
Fortified oat drink with vitamin C followed by fortified oat drink without vitamin C
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
14 days after administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PepsiCo Global R&D

Collaborators

Food and Nutrition Research Institute, Philippines

Investigators

  • Principal Investigator: Trinidad P Trinidad, PhD, FNRI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

September 1, 2011

Study Registration Dates

First Submitted

August 23, 2011

First Submitted That Met QC Criteria

August 24, 2011

First Posted (ESTIMATE)

August 25, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

September 21, 2012

Last Update Submitted That Met QC Criteria

August 22, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEP 1009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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