Modified Dosage for Moderate Acute Malnutrition (MODAM-MAM)

Официальное название

Safety Efficacy, and Cost-effectiveness of Modified Doses of Ready-to-use Therapeutic and Supplementary Foods for the Treatment of Moderate Acute Malnutrition Among Children 6-59 Months of Age in Ethiopia

Обзор

Protocols for the community-based management of acute malnutrition (CMAM) have not changed significantly for more than 20 years, with relatively complex treatment protocols and persistent supply chain challenges that have limited overall program coverage, leaving millions of malnourished children without care annually. The overarching goal of this research project is to simultaneously test two novel simplified approaches in CMAM with potential to improve program coverage. The simplified approach includes two parallel clinical trials for SAM and MAM treatment. Two fixed-dose regimes of RUTF will be tested against the current fixed-dose regimen of RUSF for children with MAM.

Вмешательства

• Пищевая добавка ready-to-use supplementary food (RUSF)
  standard formulation meeting UNICEF specifications: https://www.unicef.org/supply/media/16636/file/S0000248-RUSF-Specification.pdf
• Пищевая добавка ready-to-use therapeutic food (RUTF)
  standard formulation meeting UNICEF specifications: https://www.unicef.org/supply/sites/unicef.org.supply/files/2023-04/U239977-RUTF-Novel-Specification.pdf

Первичные конечные точки

• short-term nutritional recovery from MAM [Срок оценки: up to 16 weeks]

Вторичные конечные точки (12)

• weight gain during treatment [Срок оценки: weekly for up to 16 weeks]
• mid-upper-arm circumference (MUAC) gain during treatment [Срок оценки: weekly for up to 16 weeks]
• length/height gain during treatment [Срок оценки: weekly for up to 16 weeks]
• changes to phase angle (PhA) as measured by bioelectrical impedance analysis [Срок оценки: up to weekly for up to 16 weeks]
• changes to extracellular water (ECW) as measured by bioelectrical impedance analysis [Срок оценки: up to weekly for up to 16 weeks]
• changes to total body water (TBW) as measured by bioelectrical impedance analysis [Срок оценки: up to weekly for up to 16 weeks]
• changes to fat free mass as measured by bioelectrical impedance analysis [Срок оценки: up to weekly for up to 16 weeks]
• changes in immunological function during treatment as measured by quantification of T-cell recombination excision circles (TRECs) and kappa-deleting recombination excision circles (KRECs) on dried blood spots [Срок оценки: up to weekly for up to 16 weeks]
• rates of acute illness, including diarrhea, vomiting, and fever during treatment [Срок оценки: weekly for up to 16 weeks]
• mortality rate [Срок оценки: weekly for up to 16 weeks]
• hospitalization rate [Срок оценки: weekly for up to 16 weeks]
• duration of treatment required prior to short-term recovery [Срок оценки: weekly for up to 16 weeks]

Критерии участия

Критерии включения

• Age 6-59 months
• Reside in the catchment area of the health post where the trial is to be conducted without plans to leave the area over the next year
• Uncomplicated moderate acute malnutrition, as defined by no signs of severe illness that would require referral to inpatient facility
• Pass appetite test conducted at the time of enrollment
• Consent for randomization into the study given by mother, father, and/or other primary caregiver
• Mid-upper arm circumference of 115-124 mm without nutritional edema
• Weight-for-height Z-score (WHZ) between -2 and -3

Критерии исключения

• Complicated acute malnutrition with severe illness requiring transfer to a stabilization center or hospital for treatment. This includes, but is not limited to: a. Hypothermia b. High fever c. Signs of hypoglycemia d. Lethargy or altered mental status e. Moderate to severe dehydration f. Shock g. Other medical complications requiring hospitalization or higher-level medical evaluation
• Treatment for acute malnutrition, either as an inpatient or outpatient, within the past 3 months
• Known chronic medical illness such as severe cerebral palsy, severe congenital anomalies such as unrepaired congenital heart disease, Down syndrome, hydrocephalus, unrepaired cleft lip or palate, or other conditions that would be expected to contribute to difficulty feeding the prescribed amounts of therapeutic or supplementary food

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Ethiopia · 3 центра

• Sekota — Sekota
• Teltele — Teltelē
• Gode — Gode

Публикации

• Trehan I, Beyene Y, Darsene H, Adams BS, Wrabel M, Gizaw G, Legese LA, Cichon B, Chitekwe S, Shellemew MW, Tessema M, Stobaugh HC. The Modified Dosages for Acute Malnutrition (MODAM) study: protocol for three integrated randomized controlled trials of novel approaches for the management of childhood wasting in Ethiopia. BMC Nutr. 2025 Apr 8;11(1):71. doi: 10.1186/s40795-025-01054-w. PMID 40200326

Идентификаторы

NCT: NCT06056089 · MODAM-MAM

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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