Choline to Improve Malnutrition and Enhance Cognition

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Nov 28, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether adding a special nutrient called choline to a type of therapeutic food can help improve the brain development of young children suffering from severe acute malnutrition (SAM) in Malawi. The trial will involve children aged 6 to 59 months who have signs of malnutrition, such as a very thin upper arm or swelling in their feet. Researchers want to find out if giving these children a daily dose of 500mg of choline along with their regular therapeutic food makes a difference in how well they think and learn compared to those who only receive the standard food.

To participate, children must be between 6 and 59 months old and show specific signs of malnutrition. However, those with more serious medical issues or who have recently participated in other feeding programs won't be included. Families who join the study can expect to follow certain procedures and stay in touch with the clinic for the study's duration. This trial is important because it aims to find better ways to support the health and development of children who are struggling with malnutrition, which can have lasting effects on their lives.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 6-59 months of age
• • mid-upper arm circumference \< 11.5 cm and/or weight-for-length z-score \< -3 and/or presence of bilateral pedal pitting edema
• • willingness to comply with all study procedures and availability for the duration of the study, including no plan to move from the catchment area of a participating clinic
• Exclusion Criteria:
• • features of complicated SAM: inability to tolerate a 30g test dose of RUTF, breathing difficulties, mental status changes, sepsis, or physician/nursing clinical assessment that the child needs immediate hospitalization
• • participation in a separate feeding program within the past month
• • known allergy to study food ingredient (peanut, milk, fish)
• • intention to move away from catchment area within 9 months
• • developmental delay
• • presence of a chronic severe medical condition (other than TB and HIV), such as congenital heart disease