Efficacy of Caterpillar Cereal for Complementary Feeding in the Democratic Republic of Congo (CAT02)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01282788|
Recruitment Status : Completed
First Posted : January 25, 2011
Last Update Posted : December 9, 2013
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 or disease||Intervention/treatment||Phase|
|Malnutrition Stunting of Growth Iron Deficiency Anemia Neurodevelopmental Impairment Infectious Diseases Morbidity||Dietary Supplement: Caterpillar Cereal||Not Applicable|
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.
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:
- Feed thickened gruel or cereals every day
- Feed infant/toddler at least 3 times a day
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||222 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Novel Sustainable Complementary Feeding Product for Infants and Young Children in the Democratic Republic of Congo: Caterpillar Cereal|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||December 2012|
No Intervention: Traditional Diet
Infants in communities randomized to the traditional diet arm will not receive food supplements.
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.
- Incidence of Stunting of Linear Growth [ Time Frame: 18 months of age ]Stunting of linear growth will be defined as a height-for-age Z score less than 2 using WHO standards.
- Rate of Head Growth [ Time Frame: 18 months of age ]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 ]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 ]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 ]Infectious morbidities will be identified during weekly interviews of mothers by study personnel.
- All Cause Mortality [ Time Frame: 6-18 months ]Deaths will be reported to study personnel by family members or local health officials.
- Compliance [ Time Frame: 6-18 months ]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 ]We will measure serum markers of iron deficiency, including hemoglobin levels, ferritin and soluble transferrin receptor.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01282788
|Kinshasa School of Public Health|
|Kinshasa, Congo, B.P. 11850|
|Principal Investigator:||Carl L Bose, MD||University of North Carolina, Chapel Hill|