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Nutributter Programming to Prevent Undernutrition: an Evaluation (NPPU)

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ClinicalTrials.gov Identifier: NCT01552512
Recruitment Status : Completed
First Posted : March 13, 2012
Last Update Posted : August 6, 2018
Sponsor:
Collaborators:
University of California, Davis
World Bank
United Nations World Food Programme (WFP)
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Undernutrition Dietary Supplement: Nutributter Program Other: Integrated Package Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Control Trial of Complementary Food to Prevent Undernutrition Among At-Risk Infants in Fort San Michel, Haiti
Actual Study Start Date : June 2011
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Arm Intervention/treatment
No Intervention: MSPP Integrated Package
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.
Experimental: Nutributter 3 Months, Integrated Package
Participants receive a one-month supply for the first 3 months of the 6-month trial in addition to the Integrated Package.
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 Name: Nutriset

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).

Experimental: Nutributter 6 Months, Integrated Package
Participants receive a one-month supply for each month of the 6-month trial in addition to the Integrated Package.
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 Name: Nutriset

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).




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   6 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Moderately or severely malnourished
  • Peanut allergy

Information from the National Library of Medicine

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): NCT01552512


Locations
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Haiti
Hopital Fort San Michel
Cap Haitien, Haiti
Sponsors and Collaborators
Washington University School of Medicine
University of California, Davis
World Bank
United Nations World Food Programme (WFP)
Investigators
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Principal Investigator: Lora Iannotti, PhD Washington University School of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01552512     History of Changes
Other Study ID Numbers: FSM-001-201101760
First Posted: March 13, 2012    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: August 2018

Keywords provided by Washington University School of Medicine:
Stunting
Hidden Hunger
Diarrhea
Vitamin A Deficiency

Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders