Efficacy of Caterpillar Cereal for Complementary Feeding in the Democratic Republic of Congo (CAT02)

This study has been completed.
Sponsor:
Collaborators:
Kinshasa School of Public Health
University of California, Davis
Bill and Melinda Gates Foundation
Thrasher Research Fund
Information provided by (Responsible Party):
Carl Bose, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01282788
First received: January 21, 2011
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Malnutrition
Stunting of Growth
Iron Deficiency Anemia
Neurodevelopmental Impairment
Infectious Diseases Morbidity
Dietary Supplement: Caterpillar Cereal

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Novel Sustainable Complementary Feeding Product for Infants and Young Children in the Democratic Republic of Congo: Caterpillar Cereal

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Incidence of Stunting of Linear Growth [ Time Frame: 18 months of age ] [ Designated as safety issue: No ]
    Stunting of linear growth will be defined as a height-for-age Z score less than 2 using WHO standards.


Secondary Outcome Measures:
  • Rate of Head Growth [ Time Frame: 18 months of age ] [ Designated as safety issue: No ]
    Head circumference will be measured at enrollment (6 months of age) and conclusion of the study (18 months of age).

  • Incidence of wasting [ Time Frame: 18 months of age ] [ Designated as safety issue: No ]
    Wasting will be defined as weight-for-age Z score less than 2 using the WHO growth standards.

  • Developmental Outcome [ Time Frame: 18 months of age ] [ Designated as safety issue: No ]
    The Ages and Stages Questionnaire and the Bayley Scale of Infant Development II will be used to determine developmental outcome at 18 months of age.

  • Infectious Disease Morbidity [ Time Frame: 6-18 months ] [ Designated as safety issue: Yes ]
    Infectious morbidities will be identified during weekly interviews of mothers by study personnel.

  • All Cause Mortality [ Time Frame: 6-18 months ] [ Designated as safety issue: Yes ]
    Deaths will be reported to study personnel by family members or local health officials.

  • Compliance [ Time Frame: 6-18 months ] [ Designated as safety issue: No ]
    Compliance with study protocol will be assessed by study personnel through interviewers with the mothers, direct observation, and recovery of unused cereal.

  • Iron Deficiency Anemia [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    We will measure serum markers of iron deficiency, including hemoglobin levels, ferritin and soluble transferrin receptor.


Enrollment: 222
Study Start Date: January 2011
Study Completion Date: December 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Traditional Diet
Infants in communities randomized to the traditional diet arm will not receive food supplements.
Experimental: Cereal
All infants in communities randomized to the Cereal Arm will receive caterpillar cereal from 6-18 months of age.
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.

Detailed Description:

A randomized, controlled trial will be conducted in the Equateur Province. The study will be a cluster randomized, non-masked controlled trial of a daily intake of caterpillar cereal (Cereal Arm) versus the usual diet provided by the family (Traditional Diet Arm) from 6 to18 months of age. Eight communities (clusters) will be randomized to either the Cereal Arm or the Traditional Diet Arm of the study. A community will be comprised of approximately 10 to 12 rural villages served by one Health Center. Each Cereal community will be paired with a Traditional Diet community.

Educational Information

All participants will be provided with general education that will include: 1) critical messages about infant feeding and 2) instruction about hand hygiene and food preparation. The primary educators will be the Community Coordinators (CCs; specially-trained research nurses) working with the Health Center nurses. Messages will be delivered and reinforced with pictorial aids. Mothers in both arms will receive three repetitive messages to reinforce selected features of World Health Organization (WHO) recommendations for complementary feeding:

  1. Feed thickened gruel or cereals every day
  2. Feed infant/toddler at least 3 times a day
  3. Maximize local food diversity

Cereal Arm All infants in communities randomized to the Cereal Arm 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 CCs, 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.

Traditional Diet Arm Infants in communities randomized to the Traditional Diet Arm will not receive food supplements. Parents and other care providers in this arm of the study will receive general education about feeding practices, food preparation and hygiene, with weekly reinforcement.

Study Population A total of 220 infants (approximately 27 from each community; 110 infants in each arm) will be enrolled in the study. Records of all births within study communities will be obtained from local Health Center records. When infants reach 5 months of age, caregivers of randomly selected infants will be approached by CCs to seek consent for participation in this study. They will be supported by the Provincial Coordinator (the physician who oversees community-based studies conducted by the Kinshasa School of Public Health-University of North Carolina Partnership) who will hold group information meetings to introduce the study to community leaders.

  Eligibility

Ages Eligible for Study:   6 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01282788

Locations
Congo
Kinshasa School of Public Health
Kinshasa, Congo, B.P. 11850
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Kinshasa School of Public Health
University of California, Davis
Bill and Melinda Gates Foundation
Thrasher Research Fund
Investigators
Principal Investigator: Carl L Bose, MD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: Carl Bose, MD, Prinicipal investigator, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01282788     History of Changes
Other Study ID Numbers: 10-2071
Study First Received: January 21, 2011
Last Updated: December 5, 2013
Health Authority: Congo, Democratic Republic of the: Ministry of Health
United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
infant nutrition
complementary feeding
malnutrition
stunting of growth

Additional relevant MeSH terms:
Anemia
Communicable Diseases
Infection
Deficiency Diseases
Anemia, Iron-Deficiency
Malnutrition
Nutrition Disorders
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 25, 2014