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Iron Bioavailability of Fortified Oat Drink

NCT ID: NCT01423162

Last Updated: 2012-09-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2011-09-30

Brief Summary

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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

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Conditions

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Iron Absorption

Keywords

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Iron absorption Oats fortified oat beverages

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Dietary Intervention (with Vit C then without Vit C)

Intervention Type OTHER

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

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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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

Interventions

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Dietary Intervention (with Vit C then without Vit C)

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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Food and Nutrition Research Institute, Philippines

OTHER_GOV

Sponsor Role collaborator

PepsiCo Global R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Trinidad P Trinidad, PhD

Role: PRINCIPAL_INVESTIGATOR

FNRI

Locations

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Food and Nutrition Research Institute

City of Taguig, , Philippines

Site Status

Countries

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Philippines

Other Identifiers

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PEP 1009

Identifier Type: -

Identifier Source: org_study_id