Effect of Nutritional Formula Supplementation on Growth of Prepubertal Children Treated With Stimulants Medications for ADHD. A Randomized Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- height standard deviation score (SDS)
研究概览
简要总结
The proposed study is a double blind, randomized, placebo controlled study. The aim of the study is to evaluate the effect of nutritional formula supplementation on growth of prepubertal children treated with stimulants medications of ADHD.
70 Participants treated with stimulants medications of ADHD will be randomly assigned either to the intervention group or the placebo control group. Randomization for the two study groups will be made in a ratio of 1:1. Both participants and study team will be blinded to the type of treatment that each patient will receive during the study. Randomization will be stratified according to gender.
Participants in the intervention groups will be treated with the study formula and participants in the control group will be treated with a placebo low caloric formula (Powder added to water). The study will continue for 6 months of intervention versus active placebo, with additional 6 months (an extension period), in which participants at both groups, the intervention and the placebo, will be offered to continue their participation in the study with the active study supplement.
In addition, 30 prepubertal healthy siblings will be recruited to the study in order to compare baseline eating and physical activity patterns of ADHD children treated with stimulants to their healthy untreated siblings at the same age range. Participants' siblings will only complete once the nutritional and physical activity questionnaire and report height and weight measurements.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- — 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Boys aged ≤ 10 years and girls aged ≤ 9 years.
- •Children treated with stimulants medications for ADHD for at list 3 months.
- •Prepubertal -Tanner stage 1 (gonadarche) (boys: testicular volume < 4, girls: breast at Tanner stage 1)
- •Normal weight status: BMI-SDS ≤ 85th percentile for age and gender according to the CDC 2000 growth charts
- •Signing inform consent forms
排除标准
- •Diagnosis of GH Deficiency or treatment with GH
- •Any known chronic disease or dysmorphic syndrome including bone diseases, organic brain diseases, neurological disease, past or current malignancy, chronic cardiac, renal or pulmonary problems
- •Any known gastrointestinal disease including malabsorption
- •Any known organic reason for growth retardation
- •Milk allergy.
- •Any chronic treatment with additional medication beside stimulants that might affect appetite, weight, or growth (for example SSRI's).
结局指标
主要结局
height standard deviation score (SDS)
时间窗: at 6 months
weight standard deviation score
时间窗: at 6 months
次要结局
- BMI SDS(at 6 months)
- Lean body mass(at 6 months)
- Change in ADHD symptoms measured by Vanderblit ADHD Parent Rating Scale(at 6 months)
- Fat Mass(at 6 months)
- Muscle mass(at 6 months)
- Change in physical activity patterns measured by physical activity questionnaire(at 6 months)
- Change in dietary patterns measured by Child Eating Behaviour Questionnaire(At 6 months)