First Bites: Complementary Feeding - A Global Network Cluster Randomized Controlled Trial

Summary

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.

Conditions

• Complementary Feeding
• Infant Growth

Interventions

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)

OTHER

Cereal

Daily intake of an equi-caloric fortified cereal as complementary feed from 6 to 18 months.

Sponsors & Collaborators

• Kinshasa School of Public Health

  collaborator OTHER

• University of Zambia

  collaborator OTHER

• INCAP, Chiimaltenango, Guatemala

  collaborator UNKNOWN

• Aga Khan University

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• University of North Carolina, Chapel Hill

  collaborator OTHER

• University of Alabama at Birmingham

  collaborator OTHER

• Drexel University

  collaborator OTHER

• RTI International

  collaborator OTHER

• NICHD Global Network for Women's and Children's Health

  lead NETWORK

Study Design

Allocation

RANDOMIZED

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

3 Months

Max Age

4 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-07-31

Primary Completion

2010-04-30

Completion

2010-07-31

Countries

• Guatemala
• Pakistan
• Republic of the Congo
• Zambia

Study Locations