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Published on: September 20, 2019
Comparative effectiveness of lipid-nutrient spread supplementation regimens for moderate acute malnutrition in
Bailey A Clark1, Liya A Legese2, Yosef Beyene3,4
1Action Against Hunger USA, New York, New York, United States of America.
Insights
Both one and two daily sachets of ready-to-use therapeutic food (RUTF) are non-inferior to one daily sachet of ready-to-use supplementary food (RUSF) for moderate acute malnutrition (MAM) supplementation. Either RUTF or RUSF can be effective, with product choice depending on operational factors.
Area of Science:
- Nutritional science
- Pediatric health
- Global public health
Background:
- Moderate acute malnutrition (MAM) affects over 30 million children globally, increasing morbidity and mortality risks.
- The World Health Organization (WHO) recommends lipid-based nutrient supplements (LNS) for MAM, including ready-to-use supplementary food (RUSF) and ready-to-use therapeutic food (RUTF).
- Optimal product choice and dosing for MAM supplementation remain under investigation.
Purpose of the Study:
- To evaluate if one or two daily sachets of RUTF are non-inferior to one daily sachet of RUSF for MAM supplementation.
- To compare the efficacy and resource implications of different LNS dosing strategies for children with MAM.
Main Methods:
- A three-arm, parallel, individually randomized controlled trial (RCT) conducted in Ethiopia.
- Children aged 6-59 months with MAM were randomized to receive one RUSF sachet/day, one RUTF sachet/day, or two RUTF sachets/day.
- The primary outcome was anthropometric recovery within 16 weeks, defined by mid-upper arm circumference (MUAC) and weight-for-height z-score (WHZ).
Main Results:
- A total of 2,414 children were analyzed. Recovery proportions were 84.8% for 1-RUSF, 85.0% for 1-RUTF, and 88.1% for 2-RUTF.
- Both 1-RUTF and 2-RUTF arms met non-inferiority criteria compared to 1-RUSF.
- Anthropometric gains and length of stay were similar across arms; 2-RUTF required 1.6 times more product than 1-RUSF.
Conclusions:
- One and two daily sachets of RUTF are non-inferior to one daily sachet of RUSF for MAM supplementation.
- While two RUTF sachets showed slightly higher recovery, the marginal benefit may not outweigh increased resource demands.
- Product choice between RUTF and RUSF for MAM supplementation can be guided by supply, cost, and operational considerations.
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.