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Nutributter Programming to Prevent Undernutrition: an Evaluation

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01552512
Acronym
NPPU
Enrollment
1228
Registered
2012-03-13
Start date
2011-06-30
Completion date
2013-10-31
Last updated
2018-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Undernutrition

Keywords

Stunting, Hidden Hunger, Diarrhea, Vitamin A Deficiency

Brief 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.

Interventions

DIETARY_SUPPLEMENTNutributter 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.

OTHERIntegrated 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).

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Months to 12 Months
Healthy volunteers
No

Inclusion criteria

* Infants 6 to 12 months old * Lives in Fort San Michel

Exclusion criteria

* Moderately or severely malnourished * Peanut allergy

Design outcomes

Primary

MeasureTime frameDescription
Change in Length for AgeOnce per month for 6 months, then once after 12 months.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.

Secondary

MeasureTime frameDescription
Change in Weight for HeightOnce per month for 6 months, then once after 12 monthsWeight (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.

Countries

Haiti

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026