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

NCT01751009 | Completed

• 1 other identifier: IORG0004854
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition

Keywords

vitamin A, complementary foods, malnutrition, children

Outcome Measures

Primary Outcomes (1)

• Vitamin A status after 5 months supplementation

  5 months

Secondary Outcomes (1)

• acceptability of home based fortified vitamin A supplements

  5 months

Study Arms (2)

Vitamin A supplements

EXPERIMENTAL

Sprinkles with Vitamin A

Dietary Supplement: Vitamin A supplements

Sprinkles without Vitamin A

ACTIVE COMPARATOR

Made of other micronutrients without Vitamin A

Dietary Supplement: Sprinkles without Vitamin A

Interventions

Vitamin A supplements DIETARY_SUPPLEMENT

Sprinkles with Vitamin A

Vitamin A supplements

Sprinkles without Vitamin A DIETARY_SUPPLEMENT

Active comparator

Sprinkles without Vitamin A

Eligibility Criteria

• Age: 6 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Child's haemoglobin level less than 70 g/L.
• Unable to give informed consent

Sponsors & Collaborators

• Kintampo Health Research Centre, Ghana: lead
• University of Wisconsin, Madison: collaborator

Study Sites (1)

Kintampo North Municipality

Kintampo, Ghana

Location

Related Links

• Related Info

MeSH Terms

Conditions

Malnutrition

Interventions

Vitamin A

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Officials

• Sherry Tanumihardjo, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2012
• First Posted: December 17, 2012
• Study Start: January 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: December 17, 2012

Record last verified: 2012-12

Locations

GH (1)