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

This study has been completed.
Sponsor:
Collaborator:
University of Wisconsin, Madison
Information provided by (Responsible Party):
Kintampo Health Research Centre, Ghana
ClinicalTrials.gov Identifier:
NCT01751009
First received: November 5, 2012
Last updated: December 14, 2012
Last verified: December 2012
  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.

Resource links provided by NLM:


Further study details as provided by Kintampo Health Research Centre, Ghana:

Primary Outcome Measures:
  • Vitamin A status after 5 months supplementation [ Time Frame: 5 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01751009

Locations
Ghana
Kintampo North Municipality
Kintampo, Ghana
Sponsors and Collaborators
Kintampo Health Research Centre, Ghana
University of Wisconsin, Madison
Investigators
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 July 29, 2014