Severe Acute Malnutrition and Child Development Clinical Trial in Mwanza

Summary

This is a randomized clinical trial to learn whether ready-to-use therapeutic foods enriched with choline and docosahexaenoic acid (DHA) together with psychosocial stimulating activities work well to improve child development in children with severe acute malnutrition(SAM). The overall question this trial aims to answer is can the health and development outcomes of children with SAM be improved through optimized nutritional treatment and integrated psychosocial support.

Researchers will compare the new ready-to-use therapeutic food and an integrated psychosocial stimulation to a standard look-alike nutritional supplement that contains no additional nutrients being investigated and the standard nutritional counseling given locally and assess its effects on child development in children with severe acute malnutrition.

Participants will:

* Be given the trial interventions which will be delivered over 12 weeks
* After the 12 weeks of intervention, participants will return for outcome evaluations (week 12 study visit), which will be repeated at follow-up visits after 24 and 48 weeks.

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.

Sponsors & Collaborators

• University of Liverpool

  collaborator OTHER

• Bugando Medical Centre

  collaborator UNKNOWN

• University of Turku

  collaborator OTHER

• Rigshospitalet, Denmark

  collaborator OTHER

• University of Copenhagen

  collaborator OTHER

• Sokoine University of Agriculture

  collaborator OTHER

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• National Institute for Medical Research, Tanzania

  lead OTHER_GOV

Principal Investigators

• Mette Olsen, MSc, PhD · Rigshospitalet, Denmark

• George PrayGod, MD, PhD · National Institute for Medical Research

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

6 Months

Max Age

36 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-03

Primary Completion

2025-11-14

Completion

2026-05-14

Countries

• Tanzania

Study Locations