Complementary Feeding Clinical Trial
— First BitesOfficial title:
Complementary Feeding - A Global Network Cluster Randomized Controlled Trial
The specific aims of this project is to determine the impact of a daily intake of one half ounce of lyophilized meat between 6-18 months of age (0.5 oz for 6-12 mo; 0.75 oz for 12-18 mo) on linear growth velocity, zinc and iron intakes and status, brain growth and neurocognitive development, and infectious disease morbidity in populations traditionally dependent on non-micronutrient fortified plant foods for complementary feeding.
Status | Completed |
Enrollment | 1236 |
Est. completion date | July 2010 |
Est. primary completion date | April 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 3 Months to 4 Months |
Eligibility |
Inclusion Criteria: - Inclusion criteria for clusters: Each cluster will be a rural community characterized by inhabitants with low income and served by one community health center. A primary criterion is that national or other available statistics indicate a prevalence of stunting (mean length for age Z-scores in second year < -2) of at least 20% in young children. - Inclusion criteria for individual families: - Infant aged 3-4 months; - Primarily or exclusively breast feeding with intent to continue breast feeding through at least 1 year. Exclusion Criteria: - Exclusion criteria for individual families: Exclusion criteria include any population/family that is receiving or likely to receive free or subsidized complementary foods (or infant formula) through the health system or NGOs; any individual families who are feeding or intend to feed fortified infant formula or micronutrient-fortified commercial complementary foods. - Exclusion criteria for infants: Infants meeting the following criteria will be excluded from participation: 1. known congenital anomaly; 2. infant of multiple births; 3. known neurological deficit apparent at the time of enrollment (including seizures). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Congo | Kinshasa School of Public Health | Karawa | |
Guatemala | Institute for Nutrition of Central America and Panama (INCAP) | Chiimaltenango | |
Pakistan | Agha Khan University | Karachi | |
Zambia | University of Zambia | Lusaka |
Lead Sponsor | Collaborator |
---|---|
NICHD Global Network for Women's and Children's Health | Aga Khan University, Drexel University, INCAP, Chiimaltenango, Guatemala, Kinshasa School of Public Health, RTI International, University of Alabama at Birmingham, University of Colorado, Denver, University of North Carolina, Chapel Hill, University of Zambia |
Congo, Guatemala, Pakistan, Zambia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Linear growth velocity | 6 to 18 months of age | No | |
Secondary | Infant Zinc and Ferritin levels | 18 months | No | |
Secondary | Bayleys II | 18 months | No | |
Secondary | Incidence of diarrhea, lower respiratory infection, and malaria | 6 to 18 months | No |
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