Severe Acute Malnutrition and Child Development Clinical Trial in Mwanza

NCT06781918 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: DFC file no. 23-13-RH
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Severe acute malnutrition; Ready to use therapeutic food; Childhood development; Psychosocial stimulation; Choline; Docosahexaenoic acid (DHA)

Outcome Measures

Primary Outcomes (2)

• 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)

  Assessed at baseline, 12, 24 and 48 weeks

• Change in eye tracking scores

  Neurocognitive function assessed by eye-tracking technique

  Baseline, 12, 24 and 48 weeks

Secondary Outcomes (20)

• Level of caregiver stimulation and support

  Assessed at baseline, 12, 24 and 48 weeks

• Fatty acid composition

  at baseline and at week 12, and week 48

• Mid upper arm circumference (MUAC)

  Baseline, weekly, 12, 24 and 48 weeks

• Mortality

  12, 24 and 48 weeks

• Process evaluation

  Interviews will be conducted after the last PS session ( Week 11) , and where possible, again with the same caregivers at long term follow-up (week 24 and 48).

Study Arms (4)

eRUTF

EXPERIMENTAL

Choline and DHA enriched Ready to use therapeutic foods

Dietary Supplement: Ready to Use Therapeutic Food (RUTF)

sRUTF

PLACEBO COMPARATOR

Standard ready-to-use therapeutic foods

Dietary Supplement: Ready to Use Therapeutic Food (RUTF)

PS

EXPERIMENTAL

Psychosocial stimulation

Behavioral: Psychosocial stimulation

sNC

PLACEBO COMPARATOR

Standard nutritional counseling and psychosocial stimualtion

Behavioral: Psychosocial stimulation

Interventions

Ready to Use Therapeutic Food (RUTF) DIETARY_SUPPLEMENT

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.

eRUTF; sRUTF

Psychosocial stimulation BEHAVIORAL

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.

PS; sNC

Eligibility Criteria

• Age: 6 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute for Medical Research, Tanzania: lead
• 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

Study Sites (1)

National Institute for Medical Research

Mwanza, Tanzania

Location

Related Publications (6)

• Grantham-McGregor S, Stewart ME, Schofield WN. Effect of long-term psychosocial stimulation on mental development of severely malnourished children. Lancet. 1980 Oct 11;2(8198):785-9. doi: 10.1016/s0140-6736(80)90395-5.

  PMID: 6107460 BACKGROUND

• Olsen MF, Iuel-Brockdorff AS, Yameogo CW, Cichon B, Fabiansen C, Filteau S, Phelan K, Ouedraogo A, Wells JC, Briend A, Michaelsen KF, Lauritzen L, Ritz C, Ashorn P, Christensen VB, Gladstone M, Friis H. Early development in children with moderate acute malnutrition: A cross-sectional study in Burkina Faso. Matern Child Nutr. 2020 Apr;16(2):e12928. doi: 10.1111/mcn.12928. Epub 2019 Dec 11.

  PMID: 31823490 BACKGROUND

• Stephenson K, Callaghan-Gillespie M, Maleta K, Nkhoma M, George M, Park HG, Lee R, Humphries-Cuff I, Lacombe RJS, Wegner DR, Canfield RL, Brenna JT, Manary MJ. Low linoleic acid foods with added DHA given to Malawian children with severe acute malnutrition improve cognition: a randomized, triple-blinded, controlled clinical trial. Am J Clin Nutr. 2022 May 1;115(5):1322-1333. doi: 10.1093/ajcn/nqab363.

  PMID: 34726694 BACKGROUND

• Gera T, Pena-Rosas JP, Boy-Mena E, Sachdev HS. Lipid based nutrient supplements (LNS) for treatment of children (6 months to 59 months) with moderate acute malnutrition (MAM): A systematic review. PLoS One. 2017 Sep 21;12(9):e0182096. doi: 10.1371/journal.pone.0182096. eCollection 2017.

  PMID: 28934235 BACKGROUND

• Lelijveld N, Jalloh AA, Kampondeni SD, Seal A, Wells JC, Goyheneix M, Chimwezi E, Mallewa M, Nyirenda MJ, Heyderman RS, Kerac M. Brain MRI and cognitive function seven years after surviving an episode of severe acute malnutrition in a cohort of Malawian children. Public Health Nutr. 2019 Jun;22(8):1406-1414. doi: 10.1017/S1368980018003282. Epub 2018 Dec 3.

  PMID: 30501662 BACKGROUND

• Hoddinott J, Behrman JR, Maluccio JA, Melgar P, Quisumbing AR, Ramirez-Zea M, Stein AD, Yount KM, Martorell R. Adult consequences of growth failure in early childhood. Am J Clin Nutr. 2013 Nov;98(5):1170-8. doi: 10.3945/ajcn.113.064584. Epub 2013 Sep 4.

  PMID: 24004889 BACKGROUND

Related Links

• Levels and trends in child malnutrition: UNICEF/WHO/World Bank Group joint child malnutrition estimates: key findings of the 2023 edition

MeSH Terms

Conditions

Severe Acute Malnutrition

Condition Hierarchy (Ancestors)

Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Mette Olsen, MSc, PhD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

• George PrayGod, MD, PhD

  National Institute for Medical Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

George PrayGod, MD, PhD

CONTACT

+255714226305; george.praygod@nimr.or.tz

Belinda Kweka, MD, MSc

CONTACT

+255765025170; belinda.kweka@nimr.or.tz

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Research Scientist

Model Details: This is a 2x2 factorial randomized clinical trial which aims to study the effects of DHA and choline enriched ready to use therapeutic foods and psychosocial stimulation in the management of children with severe acute malnutrition.

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: January 17, 2025
• Study Start: February 3, 2025
• Primary Completion: November 14, 2025
• Study Completion (Estimated): May 14, 2026
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TA (1)