Malnutrition Clinical Trial
Official title:
Effectiveness of Canned Herring for Prevention of Childhood Malnutrition During the Early Rainy Season in Rural Guinea-Bissau
Verified date | February 2016 |
Source | Global Food & Nutrition Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Guinea-Bissau: Ministry of Health |
Study type | Interventional |
This study will test the effectiveness of a weekly village distribution of canned herring for prevention of malnutrition in children aged 2-5 years old during a food-insecure time of the year in rural villages in Guinea-Bissau. The study will use community health workers to conduct the herring distribution, making this a test that will provide valuable information on what could become a practical food aid supplementation practice. The primary study hypothesis is that distribution of canned herring as a weekly food supplement to families with young children at the beginning of the rainy season will prevent a seasonal decrease in weight-for-age Z-score (primary variable) of children with mild to moderate malnutrition at baseline.
Status | Completed |
Enrollment | 1200 |
Est. completion date | August 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 2 Years to 5 Years |
Eligibility |
Inclusion Criteria: - Village leaders willing to allow the study to take place in their village - Village must have community health workers who are willing to do the weekly distribution of herring to enrolled families and are able to keep the necessary records documenting the distribution. - Children age 2-5 currently living in a selected village - Parents willing to participate in the study Exclusion Criteria: - There are no eligibility exclusions for this study. - If a child is identified with severe malnutrition at the baseline measurement, the family will be advised to take the child for treatment rather than participate in the study. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Global Food & Nutrition Inc. | Alaska Seafood Marketing Institute, International Partnership for Human Development |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline in weight-for-age Z-score | baseline, 8-10 weeks | No | |
Secondary | height-for-age Z-score | baseline, 8-10 weeks | No | |
Secondary | mid upper arm circumference (MUAC) measurement | measurement of circumference of the mid upper arm | baseline, 8-10 weeks | No |
Secondary | weight | baseline, 8-10 weeks | No | |
Secondary | height | baseline, 8-10 weeks | No |
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