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临床试验/ISRCTN15258669
ISRCTN15258669已完成未知

Effectiveness of a reduced dose of ready-to-use therapeutic food (RUTF) in children under 5 years of age suffering from uncomplicated severe acute malnutrition (SAM) compared to a standard dose: a randomized, controlled, non-inferiority trial in real-life conditions in Bonzola and Nzaba Health Zones, city of Mbuji-Mayi, Kasai Oriental, DRC, in 2021

Action Against Hunger0 个研究点目标入组 1,000 人开始时间: 2022年1月25日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
1,000

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • 1. Children aged 6 to 59 months
  • 2. Only one child per sibling included in the study
  • 3. Severe acute malnutrition (weight-height index <-3 Z-score and/or mid-upper arm circumference <115 mm and/or bilateral edema (+: edema localized to the lower limbs; ++: edema localized to the lower and upper limbs)
  • 4. Without medical complications
  • 5. With conclusive appetite test
  • 6. Living in the selected health zone
  • 7. Consent to participate in the study (informed consent)
  • 8. When there are several participants in the same sibling, only the first to be included in the study will be randomized. The others will automatically be included in the same group as the first one without being randomized and will not be taken into account in the analyses

排除标准

  • 1. Inconclusive appetite test
  • 2. Siblings of SAM children: any SAM child whose brother or sister (same father, same mother) is already enrolled in the study. Be careful, he/she will have to receive the same dose as his/her brother or sister outside the study in order not to create a bias with different doses within the same family
  • 3. Declared allergy to peanut and/or milk
  • 4. Previously treated for SAM in the past 6 months, including readmissions after program dropout, relapses and medical transfers
  • 5. Malformation or disability or chronic pathologies that can affect food intake, such as cleft palate, cerebral palsy, trisomy 2, sickle cell anemia

研究者

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