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

Primary Purpose

Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Ghana
Study Type
Interventional
Intervention
Vitamin A supplements
Sprinkles without Vitamin A
Sponsored by
Kintampo Health Research Centre, Ghana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malnutrition focused on measuring vitamin A, complementary foods, malnutrition, children

Eligibility Criteria

6 Months - 12 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Kintampo North Municipality

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vitamin A supplements

Sprinkles without Vitamin A

Arm Description

Sprinkles with Vitamin A

Made of other micronutrients without Vitamin A

Outcomes

Primary Outcome Measures

Vitamin A status after 5 months supplementation

Secondary Outcome Measures

acceptability of home based fortified vitamin A supplements

Full Information

First Posted
November 5, 2012
Last Updated
December 14, 2012
Sponsor
Kintampo Health Research Centre, Ghana
Collaborators
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT01751009
Brief Title
Effects of Fortified Complementary Foods on Vitamin A Status and Body Pool Size in Ghanaian Infants.
Acronym
vitapool
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kintampo Health Research Centre, Ghana
Collaborators
University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
vitamin A, complementary foods, malnutrition, children

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin A supplements
Arm Type
Experimental
Arm Description
Sprinkles with Vitamin A
Arm Title
Sprinkles without Vitamin A
Arm Type
Active Comparator
Arm Description
Made of other micronutrients without Vitamin A
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin A supplements
Intervention Description
Sprinkles with Vitamin A
Intervention Type
Dietary Supplement
Intervention Name(s)
Sprinkles without Vitamin A
Intervention Description
Active comparator
Primary Outcome Measure Information:
Title
Vitamin A status after 5 months supplementation
Time Frame
5 months
Secondary Outcome Measure Information:
Title
acceptability of home based fortified vitamin A supplements
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherry Tanumihardjo, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kintampo North Municipality
City
Kintampo
Country
Ghana

12. IPD Sharing Statement

Links:
URL
http://www.kintampo-hrc.org
Description
Related Info

Learn more about this trial

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

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