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

Moderate acute malnutrition (MAM) poses a significant risk to over 30 million children globally, necessitating effective treatment. In 2023, the World Health Organization endorsed lipid-based nutrient supplements (LNS), specifically ready-to-use therapeutic food (RUTF) and ready-to-use supplementary food (RUSF), for supplementation.

However, the optimal product and dosing strategy for children with MAM remains unclear. The Modified Dosages for Acute Malnutrition (MODAM-MAM) trial sought to determine if one or two daily RUTF sachets were as effective as the standard of one RUSF sachet daily.

The trial, a three-arm, parallel, individually randomized controlled study in Ethiopia, enrolled children aged 6-59 months with MAM (MUAC 11.5-12.4 cm or WHZ between -3 and -2, without edema). Participants were randomly assigned to one 540-kcal RUSF sachet daily ("1-RUSF"), one 500-kcal RUTF sachet daily ("1-RUTF"), or two RUTF sachets daily ("2-RUTF").

The primary outcome measured was anthropometric recovery, defined as both MUAC ≥ 12.5 cm and WHZ ≥ -2 for two consecutive visits within 16 weeks. Intention-to-treat analysis included 2,414 children. Recovery rates were 84.8% (679/801) for 1-RUSF, 85.0% (674/793) for 1-RUTF, and 88.1% (721/818) for 2-RUTF. Both intervention arms showed non-inferiority to the standard of care (1-RUSF).

Recovery proportions were statistically non-significantly higher for 1-RUTF (+0.2 percentage points) and 2-RUTF (+3.4 percentage points), with the latter requiring 1.6 times more product than 1-RUSF. Both 1-RUSF and 1-RUTF ration use were comparable, while 2-RUTF necessitated more resources. Limitations included the use of a single RUSF formulation and earlier-than-expected case identification due to extensive screening.

The study concludes that both one RUTF and two RUTF sachets daily are non-inferior to the standard of one RUSF sachet daily for MAM supplementation. Despite the marginally higher recovery with two RUTF sachets, these benefits are not substantial enough to outweigh the increased resource demands. Thus, either RUTF or RUSF daily can be considered a viable option for supplementation, with product selection based on supply, cost, and operational factors. The trial is registered as NCT06056089 on clinicaltrials.gov.