Severe Acute Malnutrition and Child Development Clinical Trial in Mwanza

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-36
SponsorNational Institute for Medical Research, Tanzania

About this trial

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.

Eligibility criteria

Qualifiers

Age from 6-36 months.

Consent given by a caregiver older than 18 years.

Diagnosed with severe acute malnutrition (MUAC<115 mm, or WHZ ≤-3 or bipedal pitting edema).

Eligible for RUTF treatment (expanded below).

Disqualifiers

Conditions preventing the child from receiving interventions, e.g., peanut butter allergy or cleft palate.

Moderate or severe disability which significantly affects normal child development (e.g., cerebral palsy or hydrocephalus), identified using a standardized screening form.

Children of families not living in the area or planning to move from the area within the follow-up period

Trial design

Treatments tested in this trial

  • Ready to Use Therapeutic Food (RUTF)
  • Psychosocial stimulation

Treatment groups

800 Participants
are divided into 4 treatment groups

Sponsors and collaborators

National Institute for Medical Research, Tanzania

Lead sponsor

University of Liverpool

Collaborator

Bugando Medical Centre

Collaborator

University of Turku

Collaborator

Rigshospitalet, Denmark

Collaborator

University of Copenhagen

Collaborator

Sokoine University of Agriculture

Collaborator

London School of Hygiene and Tropical Medicine

Collaborator