Pilot Study on a Locally Prepared Food Supplement to Support Growth and Brain Health

Completed · Not applicable

Conditions studied: Malnutrition

In brief

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 generate pilot data for sample size estimates needed for a larger trial. The study will test the effect of a supplement prepared locally with local and imported ingredients on changes in standard anthropometric benchmarks of growth, cognition, immune function, hemoglobin and skin carotenoids in young children living in 2 villages in rural Guinea-Bissau. Children in the active intervention village will be compared with assessment-only controls in a separate village having comparable demographic characteristics. As part of the study, we will assess the feasibility of having local commercial bakers prepare the supplement.

Key facts

Study ID

NCT03319589

Run by

Tufts University

People needed

80

Starts

2016-03-01

Expected to finish

2016-07-01

Last updated by the study team

2017-10-24

Who can join

Age: 2 and older, up to 7. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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