Long Term Effects of Nutritional Supplementation on Final Height
2019年12月26日 更新者：Rabin Medical Center
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
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.
研究概览
地位
撤销
研究类型
介入性
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Petach-Tikva、以色列、49202
- Schneider Children's Medical Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
10年 至 15年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Nutritional supplementation gender specific formula
Patients at this arm will continue to consume the study formula until final height.
The formula is a gender specific 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 (255-100%) of DRI for recommended daily allowance (RDA) or adequate intake
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Patients will continue to consume the study formula until final height: gender specific powder added to water containing about 25% of recommended DRI for calories, high protein (25% of calories) and multi vitamin and mineral (255-100%) of DRI for recommended daily allowance (RDA) or adequate intake
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其他：Follow-up only
Patients who are reluctant to continue to consume the study formula will come to follow-up visits only without any intervention until final height is reached
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Patients who are reluctant to continue to consume the study formula will come to follow-up visits only without any intervention until final height is reached
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Final Height Standardized Deviation Score (SDS)
大体时间：Up to 7 years (after reaching final height:height velocity less than 1 centimeter per year)
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Up to 7 years (after reaching final height:height velocity less than 1 centimeter per year)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Weight Standard Deviation Score
大体时间：Up to 7 years (after reaching final height:height velocity less than 1 centimeter per year)
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Up to 7 years (after reaching final height:height velocity less than 1 centimeter per year)
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Body Mass Index (BMI) Standard Deviation Score
大体时间：Up to 7 years (After reaching final height: height velocity less than 1 centimeter per year)
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Up to 7 years (After reaching final height: height velocity less than 1 centimeter per year)
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|
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Duration of puberty
大体时间：Up to 7 years (After reaching full puberty:tanner stage 5)
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Duration of Puberty (in Years ) from tanner stage 2 until reaching tanner stage 5
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Up to 7 years (After reaching full puberty:tanner stage 5)
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Quality of Life
大体时间：Up to 7 years (After reaching final height:height velocity less than 1 centimeter per year)
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Quality of life as measured through Quality of Life Questionnaire
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Up to 7 years (After reaching final height:height velocity less than 1 centimeter per year)
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Self Esteem
大体时间：Up to 7 years (After reaching final height:height velocity less than 1 centimeter per year)
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Self Esteem as measured through Self Esteem Questionnaire
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Up to 7 years (After reaching final height:height velocity less than 1 centimeter per year)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2018年6月1日
初级完成 (预期的)
2022年6月1日
研究完成 (预期的)
2022年6月1日
研究注册日期
首次提交
2017年10月3日
首先提交符合 QC 标准的
2017年10月23日
首次发布 (实际的)
2017年10月26日
研究记录更新
最后更新发布 (实际的)
2019年12月27日
上次提交的符合 QC 标准的更新
2019年12月26日
最后验证
2018年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.