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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00379158
Recruitment Status : Completed
First Posted : September 21, 2006
Last Update Posted : May 30, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
  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 or disease Intervention/treatment Phase
Micronutrients Drug: Micronutrient supplements Phase 4

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 393 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (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
Study Start Date : October 2003
Estimated Study Completion Date : April 2005

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U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Secondary Outcome Measures :
  1. Motor milestone acquisition
  2. Morbidity
  3. Energy intake from complementary foods

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Months to 6 Months   (Child)
Sexes Eligible for Study:   All
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

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): 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

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00379158     History of Changes
Other Study ID Numbers: 200210085
First Posted: September 21, 2006    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

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