Efficacy of Alternative RUTFs for Treatment of Child Wasting and Prevention of Relapse
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,269
- 试验地点
- 2
- 主要终点
- Anthropometric recovery
研究概览
简要总结
Acute malnutrition is the most life-threatening form of undernutrition. Moderate and severe acute malnutrition (MAM, SAM) are effectively treated with ready-to-use therapeutic foods (RUTFs) but there is a need to lower the cost of treatment and improve treatment regimens to reduce risk of relapse MAM/SAM episodes following recovery. The currently used standard formulation of RUTF contains peanuts and dairy, which pose problems due to their high cost, the need to import ingredients to the Global South (in the case of dairy), and risk of aflatoxin (in the case of peanuts). Before alternative formulations of RUTF can be recommended, however, there is the need for data on the efficacy of these formulations on recovery rates and to what extent recovery is sustainable. Sustainable recovery implies a lower rate of post-treatment relapse.
The study objectives are as follows: (1) To assess the non-inferiority of soy-maize-sorghum (SMS-) RUTF and soy-based (S-) RUTF on treatment recovery to standard RUTF; (2) To assess the superiority of SMS-RUTF and S- RUTF on post-recovery relapse compared to standard RUTF; (3) To assess the costs of a treatment course of SMS-RUTF, S-RUTF, and standard RUTF; (4) To assess the effect of SMS-RUTF and S-RUTF on microbiome composition and intestinal inflammation
The investigators will conduct a facility-based, individually randomized controlled trial with three arms allocated in a 1:1:1 allocation ratio in 30 health facilities (Centre de Santé et Promotion Sociale [CSPS]) in Burkina Faso. The investigators will randomize 1080 children with MAM and 1080 children with uncomplicated SAM 6-59 months of age to receive treatment with one of the following RUTFs: (1) standard of care, milk- and peanut-based RUTF (control group); (2) SMS-RUTF free of milk and peanuts and high in fiber (intervention 1); or (3) S-RUTF free of milk and peanuts (intervention 2). Children will be enrolled upon presentation to facilities for MAM or uncomplicated SAM treatment. Follow up visits will be weekly during treatment for SAM children and bi-weekly during treatment for MAM children, and monthly for 3 months following discharge from treatment. The primary study outcomes include, among others, anthropometric recovery at discharge (a non-inferiority analysis) and relapse to MAM or SAM within the 3 months following recovery (a superiority analysis). The investigators will employ an activity-based micro-costing approach to collect cost data on the direct and indirect medical costs, opportunity costs to caregivers, personnel, and overheads associated with outpatient MAM or SAM treatment. Fecal samples will be collected from children at a subset of facilities (5 facilities, ~60 children per treatment arm), at enrollment (initiation of treatment), discharge from treatment, and 3-months post-discharge.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The products will be provided in identical packaging and the participants, the care providers, the investigators, and outcomes assessors will be blinded to treatment assessment. However, the products may taste different and thus participants may know that they are receiving an alternative RUTF if they are familiar with the standard RUTF product.
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
- •MUAC < 12.5 cm, or WLZ/WHZ < -2
- •Absence of clinical complications or nutritional edema
- •Pass the appetite test
- •Accompanied by caregiver or legal guardian
- •Caregiver or legal guardian consents to participate
排除标准
- •Acute malnutrition requiring hospitalization (presence of clinical complications, failure to pass the appetite test, or presence of bilateral pitting edema)
- •Known allergy to any of the ingredients in the RUTF products
- •Already enrolled in MAM or SAM treatment program
- •Presence of physical abnormalities that make measurement of anthropometry impossible
- •Caregiver has intention to move out of the study area within the next 6 months
- •Children referred from in-patient facilities to continue in ambulatory care
研究组 & 干预措施
Standard RUTF
This is the control arm of the trial, in which children will receive the standard RUTF product for treatment of acute malnutrition
干预措施: Standard RUTF (Dietary Supplement)
Soy-based RUTF
This is an interventional arm of the trial, in which children will receive an alternative formulation, a soy-based RUTF
干预措施: Soy-based RUTF (Dietary Supplement)
Soy-maize-sorghum-based RUTF
This is an interventional arm of the trial, in which children will receive an alternative formulation, a soy-maize-sorghum-based RUTF
干预措施: Soy-maize-sorghum-based RUTF (Dietary Supplement)
结局指标
主要结局
Anthropometric recovery
时间窗: At discharge, which is up to 12 weeks after admission
Weight-for-length z-score (WLZ) ≥ -2 and middle upper arm circumference (MUAC) ≥ 125 mm and absence of bilateral pitting edema for two consecutive visits
Default from treatment
时间窗: During treatment, which is up to 12 weeks after admission
Child is absent for two consecutive visits, declared a defaulter on the second visit
Relapse to wasting
时间窗: Within 3 months post-discharge
A new episode of wasting (defined as weight-for-length/height z-score \[WLZ/WHZ\] \< -2 or middle upper arm circumference \[MUAC\] \< 125 mm or presence of bilateral pitting edema) within the 3-month period following recovery from the index wasting episode, among children who recovered from their index episode
Transfer to inpatient treatment
时间窗: During treatment, which is up to 12 weeks after admission
Referral or admission to hospital for inpatient treatment during the treatment course
Weight gain
时间窗: During treatment, which is up to 12 weeks after admission
Change in child's weight (gram/kilogram/day) between weight on day of admission to treatment and day of discharge
Anthropometry
时间窗: At 3 months post-discharge
Weight-for-length/height z-score (WLZ/WHZ), middle upper arm circumference (MUAC), weight, height/length, length/height-for-age z-score (LAZ/HAZ) and weight-for-age z-score (WAZ)
Relapse to MAM
时间窗: Within 3 months post-discharge
A new episode of MAM (weight-for-length/height z-score \[WLZ/WHZ\] \<-2 and ≥-3, or middle upper arm circumference \[MUAC\] \<125 mm and ≥115 mm) within the 3-month period following recovery from the index wasting episode
Relapse to SAM
时间窗: Within 3 months post-discharge
A new episode of SAM (weight-for-length/height z-score \[WLZ/WHZ\] \< -3 or middle upper arm circumference \[MUAC\] \< 115 mm or presence of bilateral pitting edema) within the 3-month period following recovery from the index wasting episode
Hemoglobin
时间窗: At 3 months post-discharge
Hemoglobin concentration (grams/liter)
Non-response to treatment
时间窗: During treatment, which is up to 12 weeks after admission
Any of the following criteria are met: Absence of weight gain after 5 weeks or at the third visit; weight loss for more than 4 weeks in the program or at the second visit; loss of more than 5% of body weight compared to admission weight at any time; or anthropometric recovery criteria not met after 3 months of follow-up in treatment
Adherence to treatment services
时间窗: During treatment, which is up to 12 weeks after admission
Caregiver attends the recommended schedule of visits and receive ready-to-use therapeutic foods (RUTF) supply
Length of stay
时间窗: During treatment, which is up to 12 weeks after admission
The number of days between the day the child is admitted to treatment and the day the child is determined to be recovered and thus discharged from treatment
Anthropometry
时间窗: At discharge, which is up to 12 weeks after admission
Weight-for-length/height z-score (WLZ/WHZ), middle upper arm circumference (MUAC), weight, height/length, length/height-for-age z-score (LAZ/HAZ) and weight-for-age z-score (WAZ)
Hemoglobin
时间窗: At discharge, which is up to 12 weeks after admission
Hemoglobin concentration (grams/liter)
次要结局
- Morbidity(During treatment, which is up to 12 weeks after admission)
- Anemia(At 3 months post-discharge)
- Mortality(During treatment, which is up to 12 weeks after admission, or during the 3-month post-discharge follow up)
- Anemia(At discharge, which is up to 12 weeks after admission)