Canned Herring for Prevention of Childhood Malnutrition During the Early Rainy Season in Rural Guinea-Bissau

Malnutrition Clinical Trial

Official title:

Effectiveness of Canned Herring for Prevention of Childhood Malnutrition During the Early Rainy Season in Rural Guinea-Bissau

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02496247
• Other study ID #: GFN GB 2015
• Status: Completed
• Phase: N/A
• First received: April 30, 2015
• Last updated: February 10, 2016
• Start date: May 2015
• Est. completion date: August 2015

Study information

• 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

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malnutrition
• Undernutrition

Intervention

Other:
• Canned Herring
Families with children in this study arm will receive a weekly ration of herring throughout the 8-10 week study period (2 cans herring/day per study child).

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Global Food & Nutrition Inc.	Alaska Seafood Marketing Institute, International Partnership for Human Development

Outcome

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