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

NCT03319589 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-10-24

No results posted yet for this study

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 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.

Conditions

  • Malnutrition

Interventions

DIETARY_SUPPLEMENT

Supplement

locally prepared biscuit with low sugar content (less than 10% weight) designed to facilitate growth and cognitive development

Sponsors & Collaborators

  • International Partners for Human Development

    collaborator UNKNOWN

  • Tufts University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
24 Months
Max Age
84 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2016-06-30
Completion
2016-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03319589 on ClinicalTrials.gov