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Comparison of the Efficacy and Acceptability of Three Types of Micronutrient Supplements in Ghana

This study has been completed.
Sponsor:
Collaborators:
Nestlé Foundation
United States Agency for International Development (USAID)
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00379158
First received: September 20, 2006
Last updated: NA
Last verified: September 2006
History: No changes posted
  Purpose
  1. At 12 mo of age, all three intervention groups will have significantly better iron and vitamin A status than the NI group.
  2. Infants who receive the Foodlet or Nutributter will have significantly greater weight and length gains from 6 to 12 mo and higher indices of vitamin B6, riboflavin and zinc status at 12 mo of age than the infants who receive the sprinkles containing iron and vitamin A only.
  3. Infants who receive Nutributter will have significantly greater weight and length gains from 6 to 12 mo and higher indices of vitamin A and essential fatty acid (linoleic, alpha-linolenic and docosahexaenoic, DHA) status at 12 mo of age than the infants who receive the Foodlet or sprinkles.

Condition Intervention Phase
Micronutrients
 Drug: Micronutrient supplements
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Comparison of the Efficacy and Acceptability of Three Types of Micronutrient Supplements Added to Complementary Foods for Infants in Ghana

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Growth (weight, length, head circumference)
  • Hemoglobin
  • Micronutrient status (Iron, retinol, B2, B6, zinc, plasma fatty acids)

Secondary Outcome Measures:
  • Motor milestone acquisition
  • Morbidity
  • Energy intake from complementary foods

Estimated Enrollment: 393
Study Start Date: October 2003
Estimated Study Completion Date: April 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   5 Months to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • approximately 5 mo of age
  • receiving breast milk
  • free of congenital abnormality
  • expected to stay in the town for at least the subsequent six months.

Exclusion Criteria:

  • medically diagnosed chronic illness (including asthma or eczema)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00379158

Sponsors and Collaborators
University of California, Davis
Nestlé Foundation
United States Agency for International Development (USAID)
Investigators
Principal Investigator: Kathryn G Dewey, PhD University of California, Davis
Principal Investigator: Anna Lartey, PhD University of Ghana, Legon
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00379158     History of Changes
Other Study ID Numbers: 200210085-5
Study First Received: September 20, 2006
Last Updated: September 20, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
multiple micronutrient supplements
home-fortification
complementary foods
infants
Ghana

Additional relevant MeSH terms:
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013