NCT06781918|Not Yet RecruitingPhase 3DMC
Severe Acute Malnutrition and Child Development Clinical Trial in Mwanza
BRIGHTSAM
BRAIN DEVELOPMENT, GROWTH AND HEALTH IN CHILDREN WITH SEVERE ACUTE MALNUTRITION
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Sponsor study identifier
Secondary identifiers
OTHER_GRANT · DANIDA under Danish Ministry of Foreign Affairs
interventional
800
1 country
1
Study Start
February 3, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
November 14, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 14, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 14, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 3, 2024
Actual (reported)January 17, 2025
Actual (reported)February 3, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 14, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 14, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
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).
Choline and DHA enriched Ready to use therapeutic foods
Standard ready-to-use therapeutic foods
Psychosocial stimulation
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.
National Institute for Medical Research
Mwanza, Tanzania
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.
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.
Mette Olsen, MSc, PhD
Copenhagen University Hospital, Rigshospitalet
George PrayGod, MD, PhD
National Institute for Medical Research
First Submitted
December 3, 2024
First Posted
January 17, 2025
Study Start
February 3, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Standard nutritional counseling and psychosocial stimualtion
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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.
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.
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.
Primary Completion
November 14, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 14, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 17, 2025
Record last verified: 2025-01
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