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Completed

NCT Number: NCT01552512

Nutributter Programming to Prevent Undernutrition: an Evaluation

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.

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Key information

Conditions

Undernutrition Avitaminosis Deficiency Diseases Diarrhea Growth Disorders Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vitamin A Deficiency

Age range

6 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Fort San Michel

Cap-Haïtien, Haiti

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Moderately or severely malnourished
  • Peanut allergy

Treatment and study plan

Nutributter Program

Dietary Supplement

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 names: Nutriset

Integrated Package

Other

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

  1. Change in Length for Age

    Time frame: Once 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 outcomes

  1. Change in Weight for Height

    Time frame: Once per month for 6 months, then once after 12 months

    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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • United Nations World Food Programme (WFP)
  • University of California, Davis
  • World Bank

Registry information

Official study title

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

Acronym: NPPU

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 13, 2012
Registry last updated
Aug 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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