Malnutrition Clinical Trial
— CAT01Official title:
Caterpillar Cereal: Maternal and Infant Acceptability
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 micronutrients. Although supplementation with selected micronutrients 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. Maternal and infant acceptability will be evaluated in 20 mothers and their 8 month old infants. The investigators hypothesize that this cereal will be accepted by both mothers and infants: acceptability will be based on a priori definitions.
Status | Completed |
Enrollment | 40 |
Est. completion date | October 2010 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 8 Months to 10 Months |
Eligibility |
Inclusion Criteria: - Any mother-infant dyad living within each a study community in the Equateur Province. Infants must be 8-10 months of age at the time of recruitment. Exclusion Criteria: - Infants with minor inter-current illness that may interfere with oral intake - Infants of multiple gestation births - Infants with congenital anomalies - Infants likely to receive free or subsidized complementary foods (or infant formula) |
Intervention Model: Single Group 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, University of California, Davis |
Congo,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maternal acceptability | Maternal acceptability will be defined as a median score for each of 5 features (smell, taste, texture, color, consistency, overall impression) of 3 or greater on a 5 point Likert scale. | Maternal acceptability will be measured on the first day of the trial. | No |
Primary | Infant acceptability | Each mother will be provided with a one-week supply of caterpillar cereal and will be instructed to begin daily feedings for a period of one week. Infant acceptability will be defined as the consumption of greater than 75% of the total cereal allotment by all infants during the last four days of feeding. | Infant acceptability will be measured during the one week study period. | No |
Secondary | Infant tolerance | During the visits by the Community Coordinator, mothers will be asked question about the infant's health status and specifically about any signs or symptoms attributable to feeding. Tolerance will be defined as the absence of signs or symptoms attributable to cereal consumption (diarrhea or emesis unless other family members have developed these symptoms during the week of feeding). |
This outcome will be measured throughout the one week intervention. | Yes |
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