Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT03017209 |
Date of registration:
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17/12/2016 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Locally Prepared Supplement to Support Growth and Brain Health
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Scientific title:
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Study on a Locally Prepared Food Supplement to Support Growth and Brain Health |
Date of first enrolment:
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January 2017 |
Target sample size:
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1059 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT03017209 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Guinea-Bissau
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Contacts
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Name:
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Susan B Roberts, PHD |
Address:
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Telephone:
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Email:
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Affiliation:
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Tufts University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Parent or legal guardian provides consent for all children <7 years and the parent
plus the child provide consent for any child > 7 years.
- Age 15 months to 6.99 years old or any age enrolled in first grade in the same
village.
- The family plans to remain in the village for the duration of the study (up to 30
weeks) based on self-report by a parent;
- The child does not have any known food allergies as reported by the mother or
guardian.
Exclusion Criteria: If any child is identified as malnourished at baseline, defined as a
mid-upper arm circumference in the red zone of the paper tape, 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.
Age minimum:
15 Months
Age maximum:
7 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Malnutrition, Child
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Cognitive Function
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Intervention(s)
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Dietary Supplement: USAID Corn Soy Blend Plus
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Dietary Supplement: Locally-prepared bar
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Other: Placebo
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Primary Outcome(s)
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Change in cognitive function measured using executive functions tasks in children ages 15 months to 3 years
[Time Frame: baseline and 24-30 weeks after baseline testing]
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Secondary Outcome(s)
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Changes in z-scores for height (HAZ)
[Time Frame: baseline and 24-30 weeks after baseline testing]
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Mid-upper arm circumference
[Time Frame: baseline and 24-30 weeks after baseline testing]
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Hemoglobin
[Time Frame: baseline and 24-30 weeks after baseline testing]
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% Lean tissue and lean growth
[Time Frame: baseline and 24-30 weeks after baseline testing]
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Changes in weight for height Z scores
[Time Frame: baseline and 24-30 weeks after baseline testing]
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Cognitive tests for children >3 years old
[Time Frame: baseline and 24-30 weeks after baseline testing]
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Cerebral blood flow
[Time Frame: baseline and 24-30 weeks after baseline testing]
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Changes in z-scores for weight (WAZ)
[Time Frame: baseline and 24-30 weeks after baseline testing]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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