Status:
COMPLETED
Pilot Study on a Locally Prepared Food Supplement to Support Growth and Brain Health
Lead Sponsor:
Tufts University
Collaborating Sponsors:
International Partners for Human Development
Conditions:
Malnutrition
Eligibility:
All Genders
24-84 years
Phase:
NA
Brief Summary
This study is a randomized controlled pilot for a future larger trial. The goals of this pilot are: a) to assess feasibility of delivering a locally prepared supplement in rural communities, and b) to...
Detailed Description
Up to 20 children aged 24-30 months and 20 school children aged 6-6.5 years living in each of 2 villages in the Oio region of Guinea-Bissau (total study population up to 80, with no minimum recruitmen...
Eligibility Criteria
Inclusion
- Non-malnourished children within the 2 villages chosen for study
- Within the specified age range: 24-36 months for young children and 6-7 years for older children, who will also be enrolled in their local school. In the event that researchers cannot enroll at least 15 participants in each age range in each village, will extend the age range up to 35.99 months for young children and up to 6.99 years for older children.
- The family plans to remain in the village for the duration of the study;
- The child does not have any known food allergies as reported by the mother or guardian.
Exclusion
- If any child is identified as malnourished at baseline, defined as a mid-upper arm circumference in the red zone of the paper tape or a weight-for-age or height-for-age z-score of less than or equal to -3.0, the child will be excluded from the study due to malnutrition, and the parents will be advised to take the child to the nearest malnutrition clinic
Key Trial Info
Start Date :
March 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03319589
Start Date
March 1 2016
End Date
July 1 2016
Last Update
October 24 2017
Active Locations (1)
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1
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, United States, 02111