Skip to main content
OpenTrials
Completed

NCT Number: NCT01751009

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

6 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kintampo North Municipality

Kintampo, Ghana

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin A supplements

Dietary Supplement

Sprinkles with Vitamin A

Sprinkles without Vitamin A

Dietary Supplement

Active comparator

Primary outcomes

  1. Vitamin A status after 5 months supplementation

    Time frame: 5 months

Secondary outcomes

  1. acceptability of home based fortified vitamin A supplements

    Time frame: 5 months

Sponsors and collaborators

Lead sponsor

Kintampo Health Research Centre, Ghana

Other

Collaborators

  • University of Wisconsin, Madison

Registry information

Official study 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.

Acronym: vitapool

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Dec 17, 2012
Registry last updated
Dec 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.