Overview

This trial is active, not recruiting.

Condition undernutrition
Treatments nutributter program, integrated package
Sponsor Washington University School of Medicine
Collaborator University of California, Davis
Start date June 2011
End date November 2012
Trial size 612 participants
Trial identifier NCT01552512, FSM-001

Summary

This randomized, controlled effectiveness study examines Nutributter programming within an integrated package of maternal and child health services offered by Haiti's Ministry of Health (MSPP) to prevent undernutrition among young children in Haiti. The aim of the process evaluation is to better understand the uptake of Nutributter® as a complementary food in the diets of young children and its feasibility and acceptability as part of MSPP's package of services. This project is being carried out at a public hospital in Fort San Michel, an impoverished community outside of Cap Haitien, Haiti.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(No Intervention)
Participants in this arm only receive the standard care offered by the Ministry of Health (MSPP)called the Integrated Package. During the trial, they do not receive Nutributter.
integrated package
The integrated package of services are provided through the Haitian Ministry of Health and includes childhood vaccinations, family planning messages, diarrhea prevention and control (e.g. water purification methods, promotion of positive sanitation and hygiene practices such as hand washing), and the promotion of positive child feeding practices (e.g. exclusive breastfeeding for six months; increased frequency of complementary feeding; and dietary diversity).
(Experimental)
Participants receive a one-month supply for the first 3 months of the 6-month trial in addition to the Integrated Package.
nutributter program Nutriset
Nutributter is a ready-to-use nutritional supplement that provides all vitamins and minerals required for healthy growth of infants 6 to 12 months of age. The paste is packaged in 20 gram sachets. One sachet corresponds to the recommended daily dose for a child.
integrated package
The integrated package of services are provided through the Haitian Ministry of Health and includes childhood vaccinations, family planning messages, diarrhea prevention and control (e.g. water purification methods, promotion of positive sanitation and hygiene practices such as hand washing), and the promotion of positive child feeding practices (e.g. exclusive breastfeeding for six months; increased frequency of complementary feeding; and dietary diversity).
(Experimental)
Participants receive a one-month supply for each month of the 6-month trial in addition to the Integrated Package.
nutributter program Nutriset
Nutributter is a ready-to-use nutritional supplement that provides all vitamins and minerals required for healthy growth of infants 6 to 12 months of age. The paste is packaged in 20 gram sachets. One sachet corresponds to the recommended daily dose for a child.
integrated package
The integrated package of services are provided through the Haitian Ministry of Health and includes childhood vaccinations, family planning messages, diarrhea prevention and control (e.g. water purification methods, promotion of positive sanitation and hygiene practices such as hand washing), and the promotion of positive child feeding practices (e.g. exclusive breastfeeding for six months; increased frequency of complementary feeding; and dietary diversity).

Primary Outcomes

Measure
Change in Length for Age
time frame: Once per month for 6 months, then once after 12 months.

Secondary Outcomes

Measure
Change in Weight for Height
time frame: Once per month for 6 months, then once after 12 months

Eligibility Criteria

Male or female participants from 6 months up to 12 months old.

Inclusion Criteria: - Infants 6 to 12 months old - Lives in Fort San Michel Exclusion Criteria: - Moderately or severely malnourished - Peanut allergy

Additional Information

Official title Randomized Control Trial of Complementary Food to Prevent Undernutrition Among At-Risk Infants in Fort San Michel, Haiti
Principal investigator Lora Iannotti, PhD
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.