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NCT03319589 · ClinicalTrials.gov registry record · NA
Pilot Study on a Locally Prepared Food Supplement to Support Growth and Brain Health
A NA study, sponsored by Tufts University.
- Completed
- Registry status
- NA
- Development phase
- 80
- Enrollment target
NCT03319589: Completed NA study, sponsored by Tufts University.
NCT03319589 is a NA study that has completed, run by Tufts University. The registered enrollment target is 80 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03319589, a NA study, has completed, sponsored by Tufts University.
- COMPLETED
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
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.
Primary Outcome
Two measures of executive function, working memory and task-switching abilities, will be administered through play-based games by local research team members. "Spin the Pots" and "Reverse Categorization" tasks, modeled after Carlson et al., have been age modified and culturally adopted.
Interventions
- DIETARY_SUPPLEMENT Supplement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2016-03 |
| Est. Completion | 2016-07 |
| Phase | NA |
What the finished NCT03319589 record still lists
NCT03319589 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Supplement is the first listed.
NCT03319589 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03319589 about?
NCT03319589 is a clinical study titled "Pilot Study on a Locally Prepared Food Supplement to Support Growth and Brain Health". 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 ef...
What is the current status of trial NCT03319589?
This trial is currently completed. It is a NA study. The enrollment target is 80 participants. The study started on 2016-03. Estimated completion is 2016-07.
What interventions are being tested in trial NCT03319589?
The interventions under investigation include: Supplement (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03319589?
This trial is sponsored by Tufts University, which has 163 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03319589's enrollment target sits among peer trials
80 994th of 2000 higher than 941 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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