Vitamin D Supplementation and Upper Respiratory Tract Infections in Adolescent Swimmers
Vitamin D Supplementation, Upper Respiratory Tract Infections, Immune and Physical Functions in Adolescent Swimmers
Background: The medical and economic burden of upper respiratory tract infections (URTIs) is extremely high, while prevention and treatment options are limited. Therefore, there is a constant need for new methods in order to significantly decrease such morbidity. Extensive evidence shows that vitamin D is associated with respiratory health, including in the prevention and treatment of URTIs. Competitive swimmers have a high prevalence of URTIs, and can serve as a model for research in this field.
The study hypothesis is that vitamin D supplementation to young swimmers with low vitamin D levels will reduce the frequency, length, and severity of URTIs and their accompanying functional impairment, while improving cellular immune function and physical function.
Methods: After screening 100 competitive adolescent swimmers to obtain ~60 with low serum levels of vitamin D, this study group will be randomized to receive either vitamin D supplementation (2000 IU/d) or placebo, given in a double blinded fashion for three months. Participants will fill a daily questionnaire regarding frequency, length and severity of URTIs symptoms and functional impairment. Blood will be drawn to evaluate changes in vitamin D status (25(OH)D) and immune function among study participants at the beginning of the study and after supplementation. Physical function on land and in water will also be assessed.
Expected results: Increase in serum 25(OH)D levels following supplementation will significantly decrease the frequency, length and severity of URTI's and their functional impairment, while enhancing the cellular immune system function and physical capacity.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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-
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Haifa、以色列
- Maccabi Haifa Swimming Club
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Herzlyia、以色列
- Bnei Herzlyia Swimming Club
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Hod Hasharon、以色列
- Hod Hasharon Swimming Club
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Maccabim、以色列
- Maccabim-Reut Swimming Club
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- members of swimming team
- training at least 15 hours/week
- low vitamin D plasma levels (<30 ng/ml)
- signed consent forms
Exclusion Criteria:
- chronic health conditions
- taking prescription medications
- taking diet supplementations
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
安慰剂比较:安慰剂
|
sweetened water
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有源比较器:vit D
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2000 IU/day of vitamin D3 as a once-daily dose
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
URI frequency
大体时间:3 months
|
URI frequency will be measured in both groups, starting 4 weeks after initiating the suplementation.
Analysis will also assess differences by sex or initial vitamin D levels, as well as by immune function changes.
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3 months
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URI duration
大体时间:3 months
|
URI duration will be measured in both groups, starting 4 weeks after initiating the suplementation.
Analysis will also assess differences by sex or initial vitamin D levels, as well as by immune function changes.
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3 months
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UTI severity
大体时间:3 months
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URI severity will be measured in both groups, starting 4 weeks after initiating the suplementation.
Analysis will also assess differences by sex or initial vitamin D levels, as well as by immune function changes.
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3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
plasma vitamin D levels
大体时间:3 months
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3 months
|
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immune system function
大体时间:3 months
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T-cell receptor excision circles (TREC), T cell receptor repertoire, B-cell receptor excision circles (BREC).
Comparison will be made with changes in vitamin D levels and with URI characteristics.
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3 months
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physical function
大体时间:3 months
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absence from school or training, land and swimming fitness tests.
Comparison will be made with changes in vitamin D levels.
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3 months
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合作者和调查者
调查人员
- 首席研究员:Gal Dubnov-Raz, MD MSc、Sheba Medical Center
- 首席研究员:Naama W Constantini, MD、Hadassah Medical Organziation
- 首席研究员:Avner Cohen, MD、Clalit Health Services
- 首席研究员:Raz Somech, MD PhD、Sheba Medical Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
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.
vitamin D的临床试验
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Johns Hopkins UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)完全的
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GlaxoSmithKline完全的
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Johns Hopkins UniversityNational Institute of Allergy and Infectious Diseases (NIAID)尚未招聘
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Daewoong Pharmaceutical Co. LTD.尚未招聘