Long Term Effects of Nutritional Supplementation on Final Height of Short and Lean Adolescents: Follow-up Study to One-year Double-blind, Randomized, Placebo Controlled Studies to Evaluate the Effect of Nutritional Supplementation on Growth of Short and Lean Adolescent Boys and Girls
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Final Height Standardized Deviation Score (SDS)
研究概览
简要总结
The proposed study is an extension study to two ongoing double blind, randomized, placebo-controlled studies evaluating the effect of gender-specific nutritional supplementation on growth of short and lean adolescent boys and girls. The aim of the current study is to extend these short term double blind, randomized, placebo controlled studies (one in boys and one in girls) and to add an extension study, which will evaluate the long term effect of the gender specific nutritional supplementation on final height. Patients completing the ongoing studies will be offered to continue treatment with the study formula until final height. Patients reluctant to continue to consume the study formula will be offered to continue followup only during the extension study without any intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participation in the former double blind, randomized, placebo controlled study to evaluate the effect of nutritional supplementation on growth of short and lean adolescent boys (protocol no. 0676-14) and girls (protocol no. 0002-15).
- •Completing at least the double blind phase of the previous studies (protocol no 0676- 14 or 0002-15)
- •Signing informed consent forme
排除标准
- •Diagnosis of Growth Hormone Deficiency or treatment with Growth Hormone
- •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
- •Any chronic treatment with medication that might affect appetite, weight or growth
结局指标
主要结局
Final Height Standardized Deviation Score (SDS)
时间窗: Up to 7 years (after reaching final height:height velocity less than 1 centimeter per year)
次要结局
- Duration of puberty(Up to 7 years (After reaching full puberty:tanner stage 5))
- Quality of Life(Up to 7 years (After reaching final height:height velocity less than 1 centimeter per year))
- Self Esteem(Up to 7 years (After reaching final height:height velocity less than 1 centimeter per year))
- Weight Standard Deviation Score(Up to 7 years (after reaching final height:height velocity less than 1 centimeter per year))
- Body Mass Index (BMI) Standard Deviation Score(Up to 7 years (After reaching final height: height velocity less than 1 centimeter per year))