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
This trial does not accept healthy volunteersQualifiers
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
Design model
Factorial
Treatments tested in this trial
Ready to Use Therapeutic Food (RUTF)
Dietary supplementDHA \& 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.
Psychosocial stimulation
BehavioralThe 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.
Treatment groups
800 Participants
are divided into 4 treatment groupsGroup A: eRUTFExperimental treatment 1 intervention
Group B: sRUTFPlacebo comparator 1 intervention
Group C: PSExperimental treatment 1 intervention
Group D: sNCPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in MDAT scores
Development will be assessed by validated methods and include: Gross motor, fine motor, language, and psycho-emotional skills assessed by the Malawi Development assessment tool (MDAT)
Time frame
Assessed at baseline, 12, 24 and 48 weeks2
Change in eye tracking scores
Neurocognitive function assessed by eye-tracking technique
Time frame
Baseline, 12, 24 and 48 weeksSecondary outcomes
1
Level of caregiver stimulation and support
Caregiver stimulation and support assessed by Observations of Mother and Child Interactions (OMCI) questionnaire
Time frame
Assessed at baseline, 12, 24 and 48 weeks2
Fatty acid composition
\- Fatty acid composition assessed by gas chromatography
Time frame
at baseline and at week 12, and week 483
Mid upper arm circumference (MUAC)
\- MUAC assessed using non-stretchable tape measure
Time frame
Baseline, weekly, 12, 24 and 48 weeks4
Mortality
Proportion of children who die during follow-up
Time frame
12, 24 and 48 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: