The Effect of Nutritional Formula Supplementation on Linear Growth of GH Treated Prepubertal Children With Idiopathic Short Stature (ISS) After 2 Years From the Beginning of GH-therapy: 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
- 64
- 试验地点
- 1
- 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 combined growth hormone (GH) treatment &nutritional formula supplementation versus GH & placebo on growth parameters in 64 children with Idiopathic Short Stature (ISS) after the second year of GH treatment.
Participants 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. The randomization will be done 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.
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
- 5 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •GH treatment for at least 24 months due to idiopathic short stature (ISS)
- •Age 5-10 years inclusive.
- •Tanner stage 1 (gonadarche).
- •BMI <85 percentile for age and gender.
排除标准
- •Diagnosis of GH deficiency
- •Any known morbidity: chronic disease dysmorphic syndromes, bone diseases, organic brain diseases, neurological disease, past or current malignancy, chronic cardial, renal or pulmonary problems, metabolic disorders.
- •Any known gastrointestinal problem including absorption problems.
- •Any chronic treatment with medication that might affect appetite, weight or growth (for example SSRI's, steroids).
- •Any eating disorders and/or psychiatric disorder
- •Milk or other food allergies
研究组 & 干预措施
Placebo
Low caloric formula (Powder added to water) without added vitamins and minerals
干预措施: Placebo (Dietary Supplement)
Nutritional standardized supplementation formula.
Powder added to water, containing about 25% of recommended daily recommended intake (DRI) for calories, high protein (25% of calories) and multivitamin and mineral (25%-100% of DRI for recommended daily allowance (RDA) or adequate intake.
干预措施: Nutritional supplementation standardized formula (Dietary Supplement)
结局指标
主要结局
height standard deviation score (SDS)
时间窗: at 6 moths
weight standard deviation score
时间窗: at 6 months
次要结局
- Fat mass(at 6 months)
- BMI SDS(at 6 months)
- muscle mass(at 6 months)
- Lean body mass(at 6 months)
- Fat mass percentage(at 6 months)