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Набор скоро начнётся NCT07345884

Treatment of Severe Acute Malnutrition in Children 6 to 59 Months Old With Standard Ready To Use Therapeutic Food Compared to a Newly Formulated Lipid Optimized Ready To Use Therapeutic Food

Без фазы С лечением Severe Acute Malnutrition in Childhood Malnutrition, Child Neurocognition, Child

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Lipid-Optimized Ready to Use Therapeutic Food (RUTF), Ready to Use Therapeutic Food (RUTF).
Кому может быть актуально
Состояния в реестре: Severe Acute Malnutrition in Childhood, Malnutrition, Child, Neurocognition, Child. Базовые параметры: 6 мес. — 59 мес. · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Пакистан
Следующий шаг
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Официальное название

Comparison of Treatment of Severe Acute Malnutrition in Children 6 to 59 Months Old With Standard Ready To Use Therapeutic Food and Newly Formulated Lipid Optimized Ready To Use Therapeutic Food an Individual Randomized Double Blind Controlled Trial

Обзор

The goal of this randomized clinical trial is to learn if a newly formulated Lipid-Optimized Ready-to-Use Therapeutic Food (LO-RUTF) can treat severe acute malnutrition in children aged 6 to 59 months. The main questions it aims to answer are: 1. Does LO-RUTF impact physical recovery from severe acute malnutrition in participants? 2. Does LO-RUTF impact neurocognitive performance after 8 and 12 weeks of treatment? Researchers will compare LO-RUTF to standard RUTF see if our energy-dense food compares to standard issue RUTF in terms of promoting recovery from severe acute malnutrition. Participants will * Take a one-week ration of LO-RUTF or standard RUTF based on the participant's weight * Return every week for checkups, tests and to receive the next ration of assigned RUTF if eligible * Be assessed for neurocognitive function through Malawi Developmental Assessment Tool (MDAT) at three time points (before treatment, 4 weeks, 12 weeks)

Вмешательства

  • Пищевая добавка Lipid-Optimized Ready to Use Therapeutic Food (RUTF)
    Since this is a pilot trial for the study recipe, we have increased the vitamin D3 content in this RUTF as an experimental variable within this study.
  • Пищевая добавка Ready to Use Therapeutic Food (RUTF)
    This is the standard of care RUTF with UNICEF product specifications. This RUTF will be produced internationally and shipped to Pakistan.

Первичные конечные точки

  • Number of Participants Recovered from Severe Acute Malnutrition as Assessed by WHO Anthro v3.1 [Срок оценки: From enrollment to the end of treatment at 8 weeks]
Вторичные конечные точки (8)
  • Change in MDAT Scores after 8 and 12 weeks of treatment [Срок оценки: Baseline and after 8 and 12 weeks of treatment]
  • Time to Recovery from Severe Acute Malnutrition [Срок оценки: From enrollment to the end of the study period at 12 weeks]
  • Time to Recovery from Moderate Acute Malnutrition [Срок оценки: From enrollment to the end of the study period at 12 weeks]
  • Proportion of Participants with Relapse of Moderate Acute Malnutrition [Срок оценки: From enrollment to the end of the study period at 12 weeks]
  • Proportion of Participants with Relapse of Severe Acute Malnutrition [Срок оценки: From enrollment to the end of the study period at 12 weeks]
  • Number of Participants with Non-Responder Status [Срок оценки: From enrollment to the end of the study period at 12 weeks]
  • Incidence of Adverse Events [Срок оценки: From enrollment to the end of the study period at 12 weeks]
  • Incidence of Hypercalcemia, Hypervitaminosis D, or excessive DHA concentrations [Срок оценки: From baseline to the end of treatment at 8 weeks]

Критерии участия

Критерии включения

  • Children aged 6-59 months with severe acute malnutrition, i.e., MUAC <11.5 cm, and/or weight-for-height/length z-score < -3, and/or with bilateral pitting edema, with an appetite to completely consume a 30 g test feeding, and without medical complications presenting at selected rural therapeutic feeding health facilities

Критерии исключения

  • Children that are simultaneously involved in another research trial or supplemental feeding program, are developmentally delayed, have vision or hearing deficits, or have a history of milk or peanut allergy.
  • Chronic diseases such as malabsorption, chronic kidney disease, inflammatory bowel disease, congenital heart disease, endocrine disorders (e.g., hypothyroidism, growth hormone deficiencies), recurrent infections (e.g., pneumonia, cough, fever, pharyngitis), chronic respiratory diseases (e.g., asthma, lung diseases), congenital or acquired immunodeficiency, and neurological disorders

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

Пакистан · 1 центр
  • Aga Khan University — Karachi

Идентификаторы

NCT: NCT07345884 · IRB-25-1096

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗