Locally Prepared Supplement to Support Growth and Brain Health

Cognitive Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03017209
• Other study ID #: 12356
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: January 2018

Study information

• Verified date: May 2019
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a randomized controlled trial with a main goal to assess the effects of a locally-prepared food for prevention of malnutrition and stunting, in comparison with standard village practices and also a widely available aid food supplement in 8-12 villages in Guinea-Bissau. The supplement intervention will be for 24-30 weeks. The primary outcome will be cognitive tests of executive function. Secondary outcomes will be changes in standard anthropometric benchmarks of growth, hemoglobin and skin carotenoids in young children living in villages in rural Guinea-Bissau. This is a within-village randomization at the level of the family, and all children will receive a dietary intervention.

Description:

Up to 1050 children aged 15 months to 6.99 years, and older children if in 1st grade elementary school, in 8-12 villages in the Oio and Cachau regions of Guinea-Bissau will be recruited for this study along with their maternal caregiver and father. Child ages will be based on the official birth records which families possess. The mothers/primary caregivers and fathers of the children will also be recruited for simple outcome assessments. Villages will be a convenience sample chosen from villages within the network of our local research partner International Partnership for Human Development. Each village in this region has one school and one community health center per village, which will be involved in supplement distribution and some outcome assessments.

Families with enrolling children will be randomized within 8-12 villages to receive 1 of 3 supplements and if any family (defined based on the father of the children since this is a polygamous community) has more than one enrolling child all those children will be randomized to the same supplement arm.

• One supplement will be the locally-prepared bar

• One will be an isocaloric amount of porridge prepared with USAIDs Corn Soy Blend Plus, prepared as recommended in a 10:3 ratio with fortified vegetable oil.

• One supplement will be an isocaloric amount of cooked rice with vegetable oil, which is the typical local breakfast.

Villagers will be informed of the randomization after baseline testing is complete.

Following baseline measurements in children of anthropometry and body composition, grip strength, cognition, hemoglobin, and skin carotenoids, children will receive their intervention for 24-30 weeks and the same measurements taken at baseline will be repeated during the last study week. The flexible end data is given to accommodate the local rainy season and its impact on transportation. Please note that cell phone access to villages is not influenced by local weather, thus communication regarding safety issues with community health workers will remain possible throughout the entire trial.

Addendum: The pre-planned primary method of analysis was a per-protocol analysis, predefined as children consuming ≥75% of their supplement. However, a clerical error in this clinical trial registration did not describe this predetermined focus on a per-protocol population. The registration implies an intention-to-treat (ITT) analysis by default. Investigators therefore revised our analytical approach to designate the ITT cohort as the primary cohort of interest. The secondary cohort of interest is the predefined per-protocol cohort (children consuming ≥75% of their supplement).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1059
• Est. completion date: January 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Months to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Child Nutrition Disorders
• Cognitive Function
• Malnutrition
• Malnutrition, Child

Intervention

Dietary Supplement:
• Locally-prepared bar
School children in first grade will receive their supplement 5 days a week in the morning before school starts. Younger children will receive the supplement 5 days a week in the morning at the community health center, distributed by community health workers. The teachers and community health workers will record amount of supplement consumption daily during the study, and will report the information weekly to the local research team throughout the intervention period.
• USAID Corn Soy Blend Plus
School children in first grade will receive their supplement 5 days a week in the morning before school starts. Younger children will receive the supplement 5 days a week in the morning at the community health center, distributed by community health workers. The teachers and community health workers will record amount of supplement consumption daily during the study, and will report the information weekly to the local research team throughout the intervention period.

Other:
• Placebo
School children in first grade will receive their supplement 5 days a week in the morning before school starts. Younger children will receive the supplement 5 days a week in the morning at the community health center, distributed by community health workers. The teachers and community health workers will record amount of supplement consumption daily during the study, and will report the information weekly to the local research team throughout the intervention period.

Locations

Country	Name	City	State
Guinea-Bissau	International Partnership for Health Development	Bissau

Sponsors (3)

Lead Sponsor	Collaborator
Tufts University	Global Food & Nutrition Inc., Massachusetts General Hospital

Country where clinical trial is conducted

Guinea-Bissau, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Carotenoids	By Resonance Raman Spectroscopy	baseline and 24-30 weeks after baseline testing
Other	Grip strength	Using a dynamometer	baseline and 24-30 weeks after baseline testing
Other	Weight of female-caregivers and fathers		baseline and 24-30 weeks after baseline testing
Other	Head circumference of child		baseline and 24-30 weeks after baseline testing
Other	Height of female-caregivers and fathers		baseline and 24-30 weeks after baseline testing
Other	Mid upper arm circumference of female caregivers		baseline and 24-30 weeks after baseline testing
Primary	Change in cognitive function measured using executive functions tasks in children ages 15 months to 3 years		baseline and 24-30 weeks after baseline testing
Secondary	Hemoglobin		baseline and 24-30 weeks after baseline testing
Secondary	Changes in z-scores for weight (WAZ)		baseline and 24-30 weeks after baseline testing
Secondary	Changes in z-scores for height (HAZ)		baseline and 24-30 weeks after baseline testing
Secondary	Cognitive tests for children >3 years old	Looking to see changes in executive function who attend supplement distribution at least 75% of the days it is offered.	baseline and 24-30 weeks after baseline testing
Secondary	Mid-upper arm circumference		baseline and 24-30 weeks after baseline testing
Secondary	Cerebral blood flow	By infrared spectroscopy	baseline and 24-30 weeks after baseline testing
Secondary	% Lean tissue and lean growth		baseline and 24-30 weeks after baseline testing
Secondary	Changes in weight for height Z scores		baseline and 24-30 weeks after baseline testing