Efficacy and Acceptability of Ready-to-use Therapeutic Foods (RUTFs) in Indonesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- long-term acceptability
研究概览
简要总结
Severe wasting or Severe Acute Malnutrition (SAM) continues to be a major public health problem in Indonesia, affecting more than 2 million children under 5 years old. A new approach to treat SAM is called Community-based management of acute malnutrition (CMAM), which has been designed to maximize the coverage and successful treatment of children with SAM, by providing Ready to Use Therapeutic Food (RUTF) through out-patient treatment. Since 2019, UNICEF has been working intensively to facilitate the local production of RUTF. This present study aims to assess the acceptability and efficacy of three locally produced RUTFs compared to the standard peanut based RUTF.
The study will be implemented in Bogor district. A total of 300 children with uncomplicated SAM, aged 6-59 months old, meeting the inclusion criteria will be included in the study. This study is designed as a randomized controlled trial. The children will be allocated to one of the five intervention (1 control, 4 experimental) arms. Each child will receive one type of RUTF product for eight consecutive weeks. The ration given to a child will be based on the need for an intake of ~ 170 kcal/kg BW/day. Data will be collected at baseline, at weekly intervals and at exit. The primary outcome of interest for the efficacy study is the relative weight gain of children consuming each of the local RUTFs compared with those consuming the standard RUTF. The primary outcome of the acceptability of the RUTFs will be the amount of product consumed during the eight-week efficacy trial.
Differences in weight and height gain will be analyzed using ANCOVA, controlling for age, gender, food intake, and morbidity. Repeated measurement statistics will be used to analyze differences in growth patterns over the eight-week intervention.
详细描述
OBJECTIVES This study aims to assess the acceptability and efficacy to increase weight and mid upper arm circumference of children aged 6-59 months with severe acute malnutrition (SAM), of three locally produced RUTFs compared to the standard peanut based RUTF. The study will be implemented in Bogor district.
METHODOLOGY Subjects inclusion criteria are reported elsewhere.
Sample Size Calculation If the Indonesian RUTFs fulfil the WHO requirement of an average increase of 4 g/kg BW/day, a sample size of 60 children per group would allow detecting a 20% difference between control and intervention products, assuming a SD of 1.6 g/kg BW, a study design effect of 1.0, a significance of 0.05, a power of 0.80. If children fail to reach this 4 g/kg BW target and only gain 2 g/kg BW/day, the sample size would still allow detection of a 30% difference between the control product and the local product. Since it will be a five-armed intervention, a total of 300 SAM children will be recruited in Bogor district.
Anthropometric and Hemoglobin Measurements Training The training on anthropometric measurements will include repeated practice and comparison of intra- and inter-observer variation to ensure that the field team will have excellent skills in conducting the anthropometric measurements.
Hemoglobin concentration will be measured using Hemocue 201+ device by (or under direct supervision of) a medical doctor, trained in the use of the equipment.
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 (Participant, Care Provider)
盲法说明
Given the very different characteristics of the RUTFs, full masking is not possible. Caregivers/mothers are only given 1 product, and do not know of the existence of the other intervention products
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
- •Children with uncomplicated SAM (WHZ < -3 and/or MUAC <115 mm) qualified for outpatient treatment, or nutritional edema regardless of anthropometry
- •Aged 6-59 months old upon enrolment
- •Pass appetite test
- •Never received in- and outpatient treatment on SAM (including not having consumed RUTF, F75, F100 or special medical specialty food1 in the last two months
- •Willing to participate in the study (parent signed the informed consent)
排除标准
- •Body weight < 4.0 kg;
- •Uncontrolled or untreatable systemic opportunistic infection, such as active TB, HIV;
- •Obvious dysmorphic features, general mental health problems (e.g., Down syndrome, etc.), other conditions interfering with normal growth;
- •Participating in another clinical trial;
- •Any congenital disorder that interferes with normal nutrient intake; chronic conditions including but not exclusively disorders of heart, kidney or liver (children to be screened by a physician);
- •SAM with complications requiring hospital treatment (including edema +3);
- •Severe anemia (Hb<7g/dL);
- •Is a twin or multiple;
- •Allergy to milk, nuts, legumes and/or antibiotics (Amoxicillin and Ampicillin)
结局指标
主要结局
long-term acceptability
时间窗: Number of children not finishing the 8 week intervention
drop-out during the intervention
short-term acceptability
时间窗: consumption of at least 50% of RUTF provided in a 30 minute period
Passing the appetite test
weight gain over the 8 week intervention
时间窗: weight gain expressed as weight gain (g)/kg body weight per day over the 8 week intervention
weight gain (in g) over 8 week intervention
次要结局
- Morbidity during the intervention(from baseline to 8 week intervention)
- recovery rate(from baseline to end of the 8 week intervention)
- increase in height for age Z scores (HAZ)(from baseline to the end of the 8 week intervention)
- length of stay in the treatment(8 week intervention or shorter)
- Perception(based on the interview with the caregiver after the 8 week intervention)
研究者
Frank Wieringa
Senior Researcher
Institut de Recherche pour le Developpement