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

Malnutrition Clinical Trial

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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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01751009
• Other study ID #: IORG0004854
• Status: Completed
• Phase: N/A
• First received: November 5, 2012
• Last updated: December 14, 2012
• Start date: January 2010
• Est. completion date: June 2010

Study information

• Verified date: December 2012
• Source: Kintampo Health Research Centre, Ghana
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ghana:Ghana Health Service
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 12 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malnutrition

Intervention

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

Locations

Country	Name	City	State
Ghana	Kintampo North Municipality	Kintampo

Sponsors (2)

Lead Sponsor	Collaborator
Kintampo Health Research Centre, Ghana	University of Wisconsin, Madison

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitamin A status after 5 months supplementation		5 months	No
Secondary	acceptability of home based fortified vitamin A supplements		5 months	No

External Links

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