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

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ClinicalTrials.gov Identifier: NCT01751009
Recruitment Status : Completed
First Posted : December 17, 2012
Last Update Posted : December 17, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Malnutrition Dietary Supplement: Vitamin A supplements Dietary Supplement: Sprinkles without Vitamin A

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : January 2010
Primary Completion Date : June 2010
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Vitamin A status after 5 months supplementation [ Time Frame: 5 months ]

Secondary Outcome Measures :
  1. acceptability of home based fortified vitamin A supplements [ Time Frame: 5 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Kintampo Health Research Centre, Ghana
ClinicalTrials.gov Identifier: NCT01751009     History of Changes
Other Study ID Numbers: IORG0004854
First Posted: December 17, 2012    Key Record Dates
Last Update Posted: December 17, 2012
Last Verified: December 2012

Keywords provided by Kintampo Health Research Centre, Ghana:
vitamin A, complementary foods, malnutrition, children

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders
Vitamins
Vitamin A
Retinol palmitate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents