Double Blind, Randomized , Placebo Controlled Study to Evaluate the Effect of Nutritional Supplementation on Growth of Short and Lean Adolescents Boys
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 3
- 主要终点
- Weight SDS (standard deviation score)
研究概览
简要总结
Study design:
Double blind, randomized, placebo controlled study. 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.
The primary objective of the study is to assess the effect of 6-12 months treatment with nutritional supplementation standardized formula, in short and lean boys adolescents on weight Standard Deviation Score (SDS) and height SDS The Secondary Objectives of the study are to assess the effect of 6-12 months treatment with nutritional supplementation standardized formula, in short and lean boys adolescents on BMI SDS, growth velocity, time to puberty, quality of life and self-esteem The study will continue for 6 months of intervention versus active placebo, with additional optional 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 study supplement. All analyses of the effect's on primary and secondary outcome measurements will take into account the consumption rate of the study formula/placebo
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
- 10 Years 至 15 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Boys aged ≥10years old
- •Prepubertal - Tanner stage 1 (gonadarche) (testicular volume<4)
- •Height and weight ≤ 10th percentile for age and gender.
- •Height-SDS ≥ -2.5 SDS
- •BMI-SDS>-3 SDS
- •Low proportion between weight and height
- •Signing inform consent forms
排除标准
- •Diagnosis of Growth Hormone (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
研究组 & 干预措施
Nutritional supplementation standardized formula
Powder added to water, containing about 25% of recommended Daily Recommended Intake (DRI) for Calories, high protein (25% of calories) and multi vitamin and mineral (25%-100% of DRI for recommended daily allowance (RDA) or adequate intake )
干预措施: Nutritional supplementation standardized formula (Dietary Supplement)
Placebo comparator
Low caloric formula (Powder added to water), without added vitamins and mineral
干预措施: Placebo comparator (Dietary Supplement)
结局指标
主要结局
Weight SDS (standard deviation score)
时间窗: At 6 months
Height SDS (standard deviation score)
时间窗: At 6 months
Height SDS (standard deviation score)
时间窗: At 12 months
Weight SDS (standard deviation score)
时间窗: At 12 months
次要结局
- BMI SDS (standard deviation score)(At 6 months)
- Growth velocity(At 6 months)
- Self-esteem (Self-Esteem Questionnaire)(At 6 months)
- Quality of life(At 6 months)
- BMI SDS (standard deviation score)(At 12 months)
- Growth velocity(At 12 months)
- Quality of life(At 12 months)
- Self-esteem (Self-Esteem Questionnaire)(At 12 months)