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

Study Overview
=================
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.

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

Conditions
-----------------
Malnutrition

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin A supplements
* Dietary Supplement: Sprinkles without Vitamin A


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 12 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin A supplements<br>Sprinkles with Vitamin A | Dietary Supplement: Vitamin A supplements<br>* Sprinkles with Vitamin A<br>|
| Active Comparator: Sprinkles without Vitamin A<br>Made of other micronutrients without Vitamin A | Dietary Supplement: Sprinkles without Vitamin A<br>* Active comparator<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin A status after 5 months supplementation |  | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acceptability of home based fortified vitamin A supplements |  | 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vitamin A, complementary foods, malnutrition, children