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

Not Applicable

Completed

• Conditions: Malnutrition
• Interventions: Dietary Supplement: Vitamin A supplements; Dietary Supplement: Sprinkles without Vitamin A

• Registration Number: NCT01751009
• Lead Sponsor: Kintampo Health Research Centre, Ghana

Brief Summary

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.

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 Timeline

• Study Start: 2010-01
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Study First Submitted: 2012-11-05
• Status Verified: 2012-12
• Study First Submitted QC: 2012-12-14
• Last Update Submitted: 2012-12-14
• Study First Posted: 2012-12-17
• Last Update Posted: 2012-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin A supplements	Vitamin A supplements	Sprinkles with Vitamin A
Sprinkles without Vitamin A	Sprinkles without Vitamin A	Made of other micronutrients without Vitamin A

Primary Outcome Measures

Name	Time	Method
Vitamin A status after 5 months supplementation	5 months

Secondary Outcome Measures

Name	Time	Method
acceptability of home based fortified vitamin A supplements	5 months

Trial Locations

Locations (1)

Kintampo North Municipality; 🇬🇭 Kintampo, Ghana