First Bites: Complementary Feeding - A Global Network Cluster Randomized Controlled Trial (First Bites)
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ClinicalTrials.gov Identifier: NCT01084109 |
Recruitment Status :
Completed
First Posted : March 10, 2010
Last Update Posted : November 25, 2013
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Condition or disease | Intervention/treatment | Phase |
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Complementary Feeding Infant Growth | Other: Lyophilized meat Other: Cereal | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1236 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Official Title: | Complementary Feeding - A Global Network Cluster Randomized Controlled Trial |
Study Start Date : | July 2008 |
Actual Primary Completion Date : | April 2010 |
Actual Study Completion Date : | July 2010 |
Arm | Intervention/treatment |
---|---|
Active Comparator: 1
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)
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Other: Lyophilized meat
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) |
Active Comparator: 2
Daily intake of an equi-caloric fortified cereal as complementary feed from 6 to 18 months.
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Other: Cereal
Daily intake of an equi-caloric fortified cereal as complementary feed from 6 to 18 months. |
- Linear growth velocity [ Time Frame: 6 to 18 months of age ]
- Infant Zinc and Ferritin levels [ Time Frame: 18 months ]
- Bayleys II [ Time Frame: 18 months ]
- Incidence of diarrhea, lower respiratory infection, and malaria [ Time Frame: 6 to 18 months ]

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Ages Eligible for Study: | 3 Months to 4 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.
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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.
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Exclusion criteria for infants: Infants meeting the following criteria will be excluded from participation:
- known congenital anomaly;
- infant of multiple births;
- known neurological deficit apparent at the time of enrollment (including seizures).

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): NCT01084109
Congo | |
Kinshasa School of Public Health | |
Karawa, Congo | |
Guatemala | |
Institute for Nutrition of Central America and Panama (INCAP) | |
Chiimaltenango, Guatemala | |
Pakistan | |
Agha Khan University | |
Karachi, Pakistan | |
Zambia | |
University of Zambia | |
Lusaka, Zambia |
Responsible Party: | NICHD Global Network for Women's and Children's Health |
ClinicalTrials.gov Identifier: | NCT01084109 |
Other Study ID Numbers: |
GN CF |
First Posted: | March 10, 2010 Key Record Dates |
Last Update Posted: | November 25, 2013 |
Last Verified: | November 2013 |
Complementary feeding Infant growth Developing countries |