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

Complementary Feeding Clinical Trial

— First Bites  

Official title:

Complementary Feeding - A Global Network Cluster Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01084109
• Other study ID #: GN CF
• Status: Completed
• Phase: Phase 3
• First received: March 9, 2010
• Last updated: November 22, 2013
• Start date: July 2008
• Est. completion date: July 2010

Study information

• Verified date: November 2013
• Source: NICHD Global Network for Women's and Children's Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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.

Description:

Inadequate and inappropriate complementary feeding are major factors contributing to excess morbidity and mortality in young children. Prominent among nutrient inadequacies are those of iron and zinc. While huge campaigns are being mounted to fortify complementary foods and to distribute supplements, the effectiveness of these programs is generally uncertain and they do not reach millions of rural poor. By comparison, little support is being given to local food-based solutions. These not only require diversity of plant foods but appear to require the inclusion of meat to achieve zinc and iron requirements. Local supplies of meat are achievable but only with a concerted international and local effort. To justify this effort requires a multi-site efficacy study, the results of which, if positive, will leave no doubt that the effort required to provide sustainable local sources of meat for complementary feeds is worthwhile. The principal hypothesis to be tested is that daily intake of beef (1 oz/d for 6-12 mo and 1.5 oz/d for 12-18 mo) added to usual primarily plant-derived complementary feeds plus selected repetitive nutrition education messages results in greater linear growth velocity than does a micronutrient (including Zn and Fe) fortified equi-caloric cereal/legume supplement plus the same educational messages. Participants from four sites in the Global Network which have stunting rates > 20%, i.e. Guatemala, Pakistan and Zambia will be randomized by clusters to receive either ½ oz lyophilized beef (equivalent to 1 oz cooked beef)/d or the equi-caloric micronutrient-fortified plant-based supplement (both increasing by 50% at age 1 year). Both groups will receive three repetitive messages delivered by study coordinators and through the local health system as part of integrated health care. These are: provide a thick puree/gruel; feed complementary foods at least three times per day; and maximize dietary diversity. These interventions will be preceded by messages to promote exclusive breast feeding until 6 months and to start complementary feeding promptly at that time as far as possible. The meat or fortified cereal supplement will be provided daily in a group setting for each cluster; as necessary the food intervention and messages will be delivered at home by the assigned community coordinator or alternate. Outcome measures, obtained by a separate group of local, trained assessment workers, include: longitudinal linear growth between 6-18 months (primary outcome); weight and head circumference; assessment of dietary variety and diversity at 6,9,12, and 18 months; indices of iron, zinc and Vitamin B12 status at 18 months; neurocognitive development at 18 months; and incidence of diarrhea and lower respiratory infections. A positive multi-country, multi-culture outcome of this trial will demonstrate the efficacy of a regular intake of meat commencing at age 6 months to achieve nutritionally complete complementary feeding and will provide a strong rationale for global efforts to enhance local supplies of meat and achieve acceptance of meats as complementary food.

Recruitment information / eligibility

• 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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Complementary Feeding
• Infant Growth

Intervention

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

Locations

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

Sponsors (10)

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

Countries where clinical trial is conducted

Congo,  Guatemala,  Pakistan,  Zambia, 

Outcome

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