Efficacy of Caterpillar Cereal for Complementary Feeding in the Democratic Republic of Congo

Summary

Two in every three infants in rural areas of the Democratic Republic of Congo (DRC) suffer from stunting of linear growth by 12 months of age. Stunting presumably results from breast milk supplementation after 6 months of age with complementary foods (CF) that provide inadequate protein and micro-nutrients. Although supplementation with selected micro-nutrients may avoid certain deficiency states, CF with animal source foods may be necessary to avoid stunting. Meat is not readily available in many Central African countries. However caterpillars, which are locally available and abundant, are a common staple in adult diets and may be a suitable substitute for animal source proteins in CF. The investigators developed a cereal made from dried caterpillars that has a nutrient content that appears to be ideal for CF and demonstrated maternal and infant acceptability. This study will investigate the efficacy in prevention of stunting of growth resulting from inadequate complementary foods.

A sub-study will evaluate the biologic effects of the caterpillar cereal to determine whether caterpillar cereal prevents iron deficiency anemia, reduces the incidence of neurodevelopmental impairment or infectious diseases.

Conditions

• Malnutrition
• Stunting of Growth
• Iron Deficiency Anemia
• Neurodevelopmental Impairment
• Infectious Diseases Morbidity

Interventions

DIETARY_SUPPLEMENT

Caterpillar Cereal

Infants will receive once-daily servings of caterpillar cereal (30 g from 6-12 months of ages and 45 g from 12-18 months of ages). Study food will be delivered to homes weekly by Community Coordinators, who will also observe feedings of the cereal during the home visit. Feedings will be observed 3x/week for the first 3 weeks after enrollment, then 1x/week until 18 months of age. Parents and other care providers will receive specific instructions about cereal preparation and general education about feeding practices, food preparation and hygiene. This information will be reinforced during weekly visits.

Sponsors & Collaborators

• Kinshasa School of Public Health

  collaborator OTHER

• University of California, Davis

  collaborator OTHER

• Bill and Melinda Gates Foundation

  collaborator OTHER

• Thrasher Research Fund

  collaborator OTHER

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Carl L Bose, MD · University of North Carolina, Chapel Hill

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

18 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-01-31

Primary Completion

2012-06-30

Completion

2012-12-31

Countries

• Republic of the Congo