Effects of Fortified Complementary Foods on Vitamin A Status and Body Pool Size in Ghanaian Infants. (vitapool)

December 14, 2012 updated by: Kintampo Health Research Centre, Ghana

A Randomised Controlled Home-based Trial of the Effects of Fortified Complementary Foods on Vitamin A Status and Body Pool Size in Ghanaian Infants.

This study tried to prove that children given food supplements containing vitamin A would have better liver vitamin A stores than children given food supplements without vitamin A over a 5 month period.

Study Overview

Detailed Description

The study wanted to assess the effect of fortification of home based complementary foods on vitamin A status in Ghanaian children who receive food supplements known as Sprinkles. The study assessed the vitamin A status and body pool size in children using a test known as the modified relative dose response test (MRDR) tests and stable 13C2 retinol as a tracer, among those who receive Sprinkles with or without vitamin A through home fortification of complementary foods.

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Not Applicable

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

      • Kintampo, Ghana
        • Kintampo North Municipality

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 months to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Informed consent of mother of eligible children aged 6-12 months.

Willingness to remain in the study area for entire duration of the study.

Willingness to agree to feed the child with supplied micronutrient supplements for duration of study.

The child should have started taking complementary foods in addition to breast milk.

Child's haemoglobin level of at least 70 g/L.

Exclusion Criteria:

Child's haemoglobin level less than 70 g/L.

Unable to give informed consent

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin A supplements
Sprinkles with Vitamin A
Sprinkles with Vitamin A
Active Comparator: Sprinkles without Vitamin A
Made of other micronutrients without Vitamin A
Active comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Vitamin A status after 5 months supplementation
Time Frame: 5 months
5 months

Secondary Outcome Measures

Outcome Measure
Time Frame
acceptability of home based fortified vitamin A supplements
Time Frame: 5 months
5 months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Sherry Tanumihardjo, PhD, University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

January 1, 2010

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

November 5, 2012

First Submitted That Met QC Criteria

December 14, 2012

First Posted (Estimate)

December 17, 2012

Study Record Updates

Last Update Posted (Estimate)

December 17, 2012

Last Update Submitted That Met QC Criteria

December 14, 2012

Last Verified

December 1, 2012

More Information

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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