Malnutrition Clinical Trial
— CAT02Official title:
A Novel Sustainable Complementary Feeding Product for Infants and Young Children in the Democratic Republic of Congo: Caterpillar Cereal
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.
Status | Completed |
Enrollment | 222 |
Est. completion date | December 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Months to 18 Months |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Congo | Kinshasa School of Public Health | Kinshasa |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | Bill and Melinda Gates Foundation, Kinshasa School of Public Health, Thrasher Research Fund, University of California, Davis |
Congo,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Rate of Head Growth | Head circumference will be measured at enrollment (6 months of age) and conclusion of the study (18 months of age). | 18 months of age | No |
Secondary | Incidence of wasting | Wasting will be defined as weight-for-age Z score less than 2 using the WHO growth standards. | 18 months of age | No |
Secondary | Developmental Outcome | 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. | 18 months of age | No |
Secondary | Infectious Disease Morbidity | Infectious morbidities will be identified during weekly interviews of mothers by study personnel. | 6-18 months | Yes |
Secondary | All Cause Mortality | Deaths will be reported to study personnel by family members or local health officials. | 6-18 months | Yes |
Secondary | Compliance | Compliance with study protocol will be assessed by study personnel through interviewers with the mothers, direct observation, and recovery of unused cereal. | 6-18 months | No |
Secondary | Iron Deficiency Anemia | We will measure serum markers of iron deficiency, including hemoglobin levels, ferritin and soluble transferrin receptor. | 18 months | No |
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