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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 2010

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.

Interventions

  • Dietary Supplement: Vitamin A supplements
    • Sprinkles with Vitamin A
  • Dietary Supplement: Sprinkles without Vitamin A
    • Active comparator

Arms, Groups and Cohorts

  • Experimental: Vitamin A supplements
    • Sprinkles with Vitamin A
  • Active Comparator: Sprinkles without Vitamin A
    • Made of other micronutrients without Vitamin A

Clinical Trial Outcome Measures

Primary Measures

  • Vitamin A status after 5 months supplementation
    • Time Frame: 5 months

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 12 Months

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Kintampo Health Research Centre, Ghana
  • Collaborator
    • University of Wisconsin, Madison
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Sherry Tanumihardjo, PhD, Principal Investigator, University of Wisconsin, Madison

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