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:


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
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: 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
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014