Nutributter Programming to Prevent Undernutrition: an Evaluation

Undernutrition Clinical Trial

— NPPU  

Official title:

Randomized Control Trial of Complementary Food to Prevent Undernutrition Among At-Risk Infants in Fort San Michel, Haiti

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01552512
• Other study ID #: FSM-001-201101760
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Est. completion date: October 2013

Study information

• Verified date: August 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1228
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 12 Months

Eligibility

Inclusion Criteria:

• Infants 6 to 12 months old

• Lives in Fort San Michel

Exclusion Criteria:

• Moderately or severely malnourished

• Peanut allergy

Related Conditions & MeSH terms

• Malnutrition
• Undernutrition

Intervention

Dietary Supplement:
• Nutributter Program
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.

Other:
• 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).

Locations

Country	Name	City	State
Haiti	Hopital Fort San Michel	Cap Haitien

Sponsors (4)

Lead Sponsor	Collaborator
Washington University School of Medicine	United Nations World Food Programme (WFP), University of California, Davis, World Bank

Country where clinical trial is conducted

Haiti, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Length for Age	Length (measured in centimeters) for age is an indicator of stunting, an outcome of chronic undernutrition during the first 2 years of life. Because our primary purpose is to prevent undernutrition, we are highly interested in this measurement.	Once per month for 6 months, then once after 12 months.
Secondary	Change in Weight for Height	Weight (measured in kilograms) for height (measured in centimeters) is an indicator of moderate to severe acute malnutrition and if an infant is underweight, she/he could require immediate medical attention. We therefore weigh each participant to assess their current health status in this regard.	Once per month for 6 months, then once after 12 months