Effects of Fortified Complementary Foods on Vitamin A Status and Body Pool Size in Ghanaian Infants. (vitapool)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Malnutrition |
Dietary Supplement: Vitamin A supplements Dietary Supplement: Sprinkles without Vitamin A |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| 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. |
- Vitamin A status after 5 months supplementation [ Time Frame: 5 months ] [ Designated as safety issue: No ]
- acceptability of home based fortified vitamin A supplements [ Time Frame: 5 months ] [ Designated as safety issue: No ]
| Enrollment: | 93 |
| Study Start Date: | January 2010 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Vitamin A supplements
Sprinkles with Vitamin A
|
Dietary Supplement: Vitamin A supplements
Sprinkles with Vitamin A
|
|
Active Comparator: Sprinkles without Vitamin A
Made of other micronutrients without Vitamin A
|
Dietary Supplement: Sprinkles without Vitamin A
Active comparator
|
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.
Eligibility| Ages Eligible for Study: | 6 Months to 12 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Ghana | |
| Kintampo North Municipality | |
| Kintampo, Ghana | |
| Principal Investigator: | Sherry Tanumihardjo, PhD | University of Wisconsin, Madison |
More Information
Additional Information:
No publications provided
| Responsible Party: | Kintampo Health Research Centre, Ghana |
| ClinicalTrials.gov Identifier: | NCT01751009 History of Changes |
| Other Study ID Numbers: | IORG0004854 |
| Study First Received: | November 5, 2012 |
| Last Updated: | December 14, 2012 |
| Health Authority: | Ghana:Ghana Health Service |
Keywords provided by Kintampo Health Research Centre, Ghana:
|
vitamin A, complementary foods, malnutrition, children |
Additional relevant MeSH terms:
|
Malnutrition Nutrition Disorders Vitamin A Vitamins Retinol palmitate Micronutrients Growth Substances Physiological Effects of Drugs |
Pharmacologic Actions Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Anticarcinogenic Agents Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013