Severe Acute Malnutrition and Child Development Clinical Trial in Mwanza
NCT ID: NCT06781918
Last Updated: 2025-01-17
Study Results
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Basic Information
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NOT_YET_RECRUITING
PHASE3
800 participants
INTERVENTIONAL
2025-02-03
2026-05-14
Brief Summary
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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.
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Detailed Description
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A trial in Malawi found a positive effect on cognitive scores six months after completing nutritional therapy with RUTF with added preformed docosahexaenoic acid (DHA), a long-chain polyunsaturated fatty acid (PUFA) of the n-3 series, which is essential for neural growth. There is also a potential for improving the content of other nutrients of importance for neurodevelopment in early childhood like choline, which is essential for neurotransmitter synthesis and phospholipids in the brain. Studies have indicated a synergistic relationship between n-3 EFAs and choline, suggesting that low levels of one or both may negatively impact cognition.
Deficits in child development associated with SAM are not only caused by inadequate diets. Families exposed to malnutrition are often affected by psychological distress, consequently children are likely to be offered little stimulation and responsive care. However, in practice, support for psychosocial stimulation and responsive caregiving is rarely offered during hospital-based treatment, and it is still not included in the guidelines for community-based treatment of SAM. The intensity of this intervention is difficult under the constraints of most health services in low- and middle-income countries (LMIC). More recent packages for promoting responsive care have shown some effects, but often not when implemented at scale or within systems of care.
In this study we hypothesize that optimized nutritional treatment and integrated psychosocial support can improve the health and development outcomes of children with SAM.
Specific objectives:
1. to assess the effects of a modified RUTF and psychosocial stimulation, individually and combined, on attention, cognitive, motor, language and psycho-emotional development in children treated for SAM;
2. to investigate the pathways of intervention effects on cognitive development by assessing the role of DHA and choline status in the child as well as caregiver factors which include caregiver-child interaction, home stimulation and maternal psychological distress;
3. to assess how, why and for whom the modified RUTF and psychosocial interventions work within the trial context, perceptions of their feasibility of implementation within the routine health system, and the climate and environmental sustainability of interventions.
Methods:
This trial is designed as a 2x2 factorial randomized clinical trial to assess the effects of DHA and choline enriched vs. standard RUTF and psychosocial stimulation vs. standard counselling in management of SAM. Participants will be individually randomised to nutritional intervention arms and clusters will be randomized to psychosocial intervention arms.
The interventions will be delivered over a period of 12 weeks. After enrolment and baseline data collection, participants will receive their first RUTF sachets. They will then be requested to return to the study site for a total of seven visits during the intervention period to receive interventions. 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. The study will take place in Mwanza region, Tanzania. The trial will include children with uncomplicated SAM aged 6-36 months from eight health care facilities in Ilemela municipality, Nyamagana municipality and Magu district.
Outcomes:
The primary outcomes is the change in child development scores, which will be assessed at baseline, 12, 24 and 48 weeks and compared with intervention groups. These will assess gross, fine motor, language and psycho -emotional skills by validated tool called (MDAT) Malawi Development Assessment Tool) and neurocognitive function will be accessed by eye-tracking. Secondary outcomes will allow us to assess proximate effects of the interventions, which may mediate long-term effects on development
Analysis:
The primary analysis will be based on the intention-to-treat principle using available case data. The analysis will assess intervention effects based on the 2x2 factorial design by comparing changes in outcomes between baseline and intervention endline (i.e., 12 weeks) using a linear regression model adjusted for sex, age and month of inclusion to account for possible seasonal effects.
Secondary analysis will include assessment of intervention effects at 24- and 48-weeks follow-up using a linear mixed model to include repeated measurements. The models will include the baseline value of the outcome as fixed effect and participant as random effect to account for the correlation between measurements from the same participant. These models will also include adjustment for other variables as appropriate.
Secondary analyses will include per-protocol analyses to assess effects within groups with high compliance with the interventions
Ethics:
Ethical approval has been sought from the Medical Research Coordinating Committee (MRCC) of the National Institute for Medical Research in Tanzania and the London School of Hygiene and Tropical Medicine ethics committee.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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eRUTF
Choline and DHA enriched Ready to use therapeutic foods
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.
sRUTF
Standard ready-to-use therapeutic foods
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.
PS
Psychosocial stimulation
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.
sNC
Standard nutritional counseling and psychosocial stimualtion
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
2. Consent given by a caregiver older than 18 years.
3. Diagnosed with severe acute malnutrition (MUAC\<115 mm, or WHZ ≤-3 or bipedal pitting edema).
4. Eligible for RUTF treatment (expanded below).
Exclusion Criteria
2. Moderate or severe disability which significantly affects normal child development (e.g., cerebral palsy or hydrocephalus), identified using a standardized screening form.
3. Children of families not living in the area or planning to move from the area within the follow-up period
6 Months
36 Months
ALL
No
Sponsors
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University of Liverpool
OTHER
Bugando Medical Centre
UNKNOWN
University of Turku
OTHER
Rigshospitalet, Denmark
OTHER
University of Copenhagen
OTHER
Sokoine University of Agriculture
OTHER
London School of Hygiene and Tropical Medicine
OTHER
National Institute for Medical Research, Tanzania
OTHER_GOV
Responsible Party
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Dr George PrayGod
Chief Research Scientist
Principal Investigators
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Mette Olsen, MSc, PhD
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
George PrayGod, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
National Institute for Medical Research
Locations
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National Institute for Medical Research
Mwanza, , Tanzania
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Related Links
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Levels and trends in child malnutrition: UNICEF/WHO/World Bank Group joint child malnutrition estimates: key findings of the 2023 edition
Other Identifiers
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DFC file no. 23-13-RH
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
DFC file no. 23-13-RH
Identifier Type: -
Identifier Source: org_study_id
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