Severe Acute Malnutrition and Child Development Clinical Trial in Mwanza

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

800

Participants

Timeline

Start Date

February 3, 2025

Primary Completion Date

November 14, 2025

Study Completion Date

May 14, 2026

Conditions
Severe Acute Malnutrition in Childhood
Interventions
DIETARY_SUPPLEMENT

Ready to Use Therapeutic Food (RUTF)

"DHA \& Choline enriched RUTF The modified RUTF is a peanut butter paste that contains vegetable oil, skim milk powder, carbohydrates, vitamins, and minerals the same nutrients which are the same as the standard RUTF but is fortified additionally with 250 mg of choline and 200 mg of preformed DHA per 92-gram sachet.~Standard RUTF The standard RUTF used in the BrightSAM trial is a peanut butter paste with vegetable oil, skim milk powder, carbohydrates, vitamins, and minerals that is intended to cover the child's total daily nutritional needs. Standard RUTF will be manufactured in compliance with the specifications recommended by the Codex Alimentarius Commission17."

BEHAVIORAL

Psychosocial stimulation

"The psychosocial intervention has been developed and piloted for this study as a context-relevant adaptation from the WHO/UNICEF Care for Child Development package. It will be delivered in group sessions, where the primary caregiver will attend along with the child participating in the trial.~During seven sessions of approximately two hours, caregivers will be trained on a variety of subjects which include; the first four sessions will be introductory and provide the basics of nutrition, the basics of psychosocial stimulation, and play and communication practices. We will build on the increasing experience of the caregivers and provide a deeper understanding of early child development.~Standard nutritional counseling will adhere to national guidelines for pediatric management of severe acute malnutrition including nutritional counseling and psychosocial stimulation."

Trial Locations (1)

Unknown

National Institute for Medical Research, Mwanza

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

University of Liverpool

OTHER

collaborator

Bugando Medical Centre

UNKNOWN

collaborator

University of Turku

OTHER

collaborator

Rigshospitalet, Denmark

OTHER

collaborator

University of Copenhagen

OTHER

collaborator

Sokoine University of Agriculture

OTHER

collaborator

London School of Hygiene and Tropical Medicine

OTHER

lead

National Institute for Medical Research, Tanzania

OTHER_GOV