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

NCT01282788 | Completed DMC

• 1 other identifier: 10-2071
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

infant nutrition; complementary feeding; malnutrition; stunting of growth

Outcome Measures

Primary Outcomes (1)

• Incidence of Stunting of Linear Growth

  Stunting of linear growth will be defined as a height-for-age Z score less than 2 using WHO standards.

  18 months of age

Secondary Outcomes (7)

• Rate of Head Growth

  18 months of age

• Incidence of wasting

  18 months of age

• Developmental Outcome

  18 months of age

• Infectious Disease Morbidity

  6-18 months

• All Cause Mortality

  6-18 months

Study Arms (2)

Traditional Diet

NO INTERVENTION

Infants in communities randomized to the traditional diet arm will not receive food supplements.

Cereal

EXPERIMENTAL

All infants in communities randomized to the Cereal Arm will receive caterpillar cereal from 6-18 months of age.

Dietary Supplement: Caterpillar Cereal

Interventions

Caterpillar Cereal DIETARY_SUPPLEMENT

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.

Cereal

Eligibility Criteria

• Age: 6 Months - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants born in study communities who will reach 6 months of age during the six month period after initiation of the study

You may not qualify if:

• Infants likely to receive free or subsidized complementary foods (or infant formula)
• Families likely to relocate during the study period
• Infants with known congenital anomaly
• Infants of multiple birth
• Infants with neurological deficit apparent at the time of enrollment

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Kinshasa School of Public Health: collaborator
• University of California, Davis: collaborator
• Bill and Melinda Gates Foundation: collaborator
• Thrasher Research Fund: collaborator

Study Sites (1)

Kinshasa School of Public Health

Kinshasa, Kinshasa, B.P. 11850, Republic of the Congo

Location

Related Publications (1)

• Bauserman M, Lokangaka A, Gado J, Close K, Wallace D, Kodondi KK, Tshefu A, Bose C. A cluster-randomized trial determining the efficacy of caterpillar cereal as a locally available and sustainable complementary food to prevent stunting and anaemia. Public Health Nutr. 2015 Jul;18(10):1785-92. doi: 10.1017/S1368980014003334. Epub 2015 Jan 29.

  PMID: 25631295 DERIVED

MeSH Terms

Conditions

Malnutrition; Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases

Study Officials

• Carl L Bose, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal investigator

Study Record Dates

• First Submitted: January 21, 2011
• First Posted: January 25, 2011
• Study Start: January 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 9, 2013

Record last verified: 2013-12

Locations

RE (1)