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Comparative effectiveness of lipid-nutrient spread supplementation regimens for moderate acute malnutrition in Ethiopia: The MODAM-MAM individually randomized controlled trial

In brief

Single-sachet RUTF achieves same 85% recovery as standard RUSF

In a trial of 2,414 Ethiopian children with moderate acute malnutrition, 85% recovered with one sachet of RUTF, matching the 84.8% recovery seen with the standard one-sachet RUSF. Two sachets of RUTF gave a modest 3-percentage-point boost but required 1.6 times more product, making the extra cost hard to justify.

Journal
PLoS medicine (Q1)
Published
11 August 2026
Study design
Randomized controlled trial
Evidence level
Level 1, High (CEBM 1b)
Authors
Bailey A Clark, Liya A Legese, Yosef Beyene, Mesfin W Shellemew, Hiwot Darsene, Stanley Chitekwe, et al.
PMID
42579725
DOI
10.1371/journal.pmed.1005199

Why clinicians should know about it

  • Picked for Breast and Endocrine Surgery (top studies of the week, 16 August 2026): Lipid‑nutrient spread for malnutrition, unrelated field
  • Picked for Pediatrics and Child Health (top studies of the week, 16 August 2026): RCT comparing LNS regimens for moderate acute malnutrition

Abstract

BACKGROUND: Moderate acute malnutrition (MAM), affecting over 30 million children globally, substantially increases the risk of morbidity and mortality. In 2023, the World Health Organization recommended lipid-based nutrient supplements (LNS) for children requiring supplementation for MAM, either ready-to-use supplementary food (RUSF) or ready-to-use therapeutic food (RUTF). However, evidence on the optimal product (RUTF or RUSF) and dosing strategy for children with MAM remains limited. The Modified Dosages for Acute Malnutrition MAM (MODAM-MAM) trial evaluated whether one- or two-sachet daily RUTF dosing were non-inferior to the de facto standard of one RUSF sachet daily for MAM supplementation. METHODS AND FINDINGS: We conducted a three-arm, parallel, individually randomized controlled trial in Ethiopia. Children aged 6-59 months with MAM (mid-upper arm circumference (MUAC) 11.5-12.4 cm or WHZ between -3 and -2, without edema) were randomized to: one 540-kcal sachet of RUSF/day ("1-RUSF"), one 500-kcal sachet of RUTF/day ("1-RUTF"), or two sachets of RUTF/day ("2-RUTF"). Both intervention arms (1-RUTF and 2-RUTF) were evaluated for non-inferiority to the standard (1-RUSF) using a prespecified 6-percentage-point margin. The primary outcome was anthropometric recovery, defined as both MUAC ≥ 12.5 cm and WHZ ≥ -2 for two consecutive visits within 16 weeks. In total, 2,414 children were analyzed in the intention-to-treat analysis. Recovery proportions were 84.8% (679/801) for 1-RUSF, 85.0% (674/793) for 1-RUTF, and 88.1% (721/818) for 2-RUTF. Risk differences for recovery relative to the standard of care (1-RUSF) were +0.2 percentage points (95% CI [-3.3, 3.7]; p = 0.944) for 1-RUTF and +3.4 percentage points (95% CI [0.0, 6.7]; p = 0.050) for 2-RUTF, with both intervention arms meeting the non-inferiority criteria. Anthropometric gains and median length of stay (56 days) were similar across arms. Ration use was comparable for 1-RUSF and 1-RUTF, while 2-RUTF required 1.6-fold more product. Study limitations include evaluation of a single RUSF formulation and earlier-than-typical case-finding due to intensive screening. CONCLUSIONS: Both experimental arms, one RUTF sachet daily and two RUTF sachets daily, are non-inferior to the standard dosing of one RUSF sachet daily for MAM supplementation. Although two sachets of RUTF daily yielded slightly higher recovery, the marginal benefits do not justify substantially greater resource demands. Because one RUTF and one RUSF sachet daily yielded similar treatment outcomes, either product can be considered an effective option for supplementation. Product choice may therefore be guided by supply, cost, and operational considerations. TRIAL REGISTRATION: clinicaltrials.gov NCT06056089.

Abstract as published, via PubMed.

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For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.