Safety Efficacy, and Cost-effectiveness of Modified Doses of Ready-to-use Therapeutic Food for the Treatment of Severe Acute Malnutrition Among Children 6-59 Months of Age in Ethiopia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,400
- 试验地点
- 3
- 主要终点
- short-term nutritional recovery from severe acute malnutrition (SAM)
研究概览
简要总结
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 weight-based dosing of RUTF for children with SAM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 severe 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 less than 115 mm and/or nutritional edema
- •Weight-for-height Z-score (WHZ) less than -3
排除标准
- •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
研究组 & 干预措施
Control Group
Standard weight-based dosing of Ready-to-Use Therapeutic Food (RUTF) at a dose of 150-200 kcal/kg/day
干预措施: ready-to-use therapeutic food (RUTF) (Dietary Supplement)
Control Group
Standard weight-based dosing of Ready-to-Use Therapeutic Food (RUTF) at a dose of 150-200 kcal/kg/day
干预措施: Amoxicillin (Drug)
SAM Experimental A
2 sachets (1000 kcal) of RUTF per day
干预措施: ready-to-use therapeutic food (RUTF) (Dietary Supplement)
SAM Experimental A
2 sachets (1000 kcal) of RUTF per day
干预措施: Amoxicillin (Drug)
SAM Experimental B
2 sachets (1000 kcal) per day while MUAC < 115mm and/or edema and/or WHZ < -3; then decreasing to 1 sachet (500 kcal) per day while MUAC 115-124 and WHZ -2 to -3 and no edema
干预措施: ready-to-use therapeutic food (RUTF) (Dietary Supplement)
SAM Experimental B
2 sachets (1000 kcal) per day while MUAC < 115mm and/or edema and/or WHZ < -3; then decreasing to 1 sachet (500 kcal) per day while MUAC 115-124 and WHZ -2 to -3 and no edema
干预措施: Amoxicillin (Drug)
结局指标
主要结局
short-term nutritional recovery from severe acute malnutrition (SAM)
时间窗: up to 16 weeks
two consecutive weeks with MUAC \> 12.4 cm and/or WHZ \>= -2 and/or resolution of edema, depending on enrollment criteria
次要结局
- changes to phase angle (PhA) as measured by bioelectrical impedance analysis(up to weekly for up to 16 weeks)
- changes to extracellular water (ECW) as measured by bioelectrical impedance analysis(up to weekly for up to 16 weeks)
- weight gain during treatment(weekly for up to 16 weeks)
- MUAC gain during treatment(weekly for up to 16 weeks)
- length/height gain during treatment(weekly for up to 16 weeks)
- mortality(up to 16 weeks)
- duration of treatment required prior to short-term recovery(up to 16 weeks)
- changes to total body water (TBW) as measured by bioelectrical impedance analysis(up to weekly for up to 16 weeks)
- medium-term rates of hospitalization(up to 6 months post-recovery)
- medium-term MUAC gain(up to 6 months post-recovery)
- medium-term total body water (TBW) as measured by bioelectrical impedance analysis(6 months post-recovery)
- changes to fat free mass as measured by bioelectrical impedance analysis(up to weekly for up to 16 weeks)
- rates of acute illness, including diarrhea, vomiting, and fever during treatment(weekly for up to 16 weeks)
- hospitalization(up to 16 weeks)
- medium-term vital status(up to 6 months post-recovery)
- medium-term nutritional status(up to 6 months post-recovery)
- medium-term length/height gain(6 months post-recovery)
- medium-term extracellular water (ECW) as measured by bioelectrical impedance analysis(6 months post-recovery)
- 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(up to weekly for up to 16 weeks)
- medium-term 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(6 months post-recovery)
- medium-term rates of relapse to SAM(up to 6 months post-recovery)
- medium-term rates of relapse to MAM(up to 6 months post-recovery)
- medium-term weight gain(up to 6 months post-recovery)
- medium-term phase angle (PhA) as measured by bioelectrical impedance analysis(6 months post-recovery)
- short-term cost-efficiency(up to 16 weeks)
- medium-term fat free mass as measured by bioelectrical impedance analysis(6 months post-recovery)
- medium-term cost-efficiency(6 months post-recovery)
研究者
Heather Stobaugh
Senior Research and Learning Specialist
Action Against Hunger USA