Importance of Dosing Regimen for the Effect of Vitamin D Supplementation
2018年5月23日 更新者：University of Tromso
Vitamin D is a hormone with effects not only on the skeleton, but on most tissues in the body.
Lack of vitamin D is associated with cardio-vascular disease (CVD), type 2 diabetes, cancer, infectious and immunological diseases, as well as risk factors for these diseases.
However, intervention studies with vitamin D have been inconclusive regarding diseases and risk factors.
This could be due to inclusion of subjects already vitamin D sufficient, and short and underpowered studies.
In addition, there are indications that the dosing regimens may be important, so that daily doses with vitamin D are more efficient than intermittent doses, which so far have been generally used.
This could be related to the concentration of circulating and thereby intracellular vitamin D concentrations, which probably is dependent on daily vitamin D doses.
This will be tested in the present study where 60 subjects will be randomized to vitamin D 160 000 once, vitamin D 4000 IU/day, or placebo for four weeks.
The primary endpoints will be effects on serum hepcidin and plasma cathelicidin after 4 weeks, with effects on serum PTH, RNA expression and microRNA in peripheral blood, telomerase activity in peripheral blood mononuclear cells and the ration between serum 1,25(OH)2D and 24,25(OH)2D as secondary endpoints.
研究概览
研究类型
介入性
注册 (实际的)
61
阶段
- 第三阶段
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
-
-
-
Tromsø、挪威、9038
- University Hospital of North Norway
-
-
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
20年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:- Males and females 20 - 70 years
- 20 kg/m2 > BMI < 35 kg/m2
- systolic BP < 175 mmHg, diastolic BP < 105 mmHg
- Serum 25(OH)D level < 50 nmol/L. Serum 25(OH)D < 50 nmol/L is considered as vitamin D deficiency, and accordingly, effects of vitamin D supplementation will be easier to detect than if the included subjects were vitamin D sufficient.
- Hgb, SR, CRP, creatinine < 130 umol/L in males, < 120 umol/L in females, calcium, FT4 and TSH within the normal reference range; ASAT < 90 mU/L ALAT < 140 U/L, HbA1c < 6.6 %
- The subjects must agree not to take any vitamin D supplementation, including cod liver oil or "mølje", use solarium or go on sunny vacation during the intervention period.
Exclusion Criteria:
- subjects allergic to peanuts
- subjects with primary hyperparathyroidism
- granulomatous diseases (sarcoidosis, tuberculosis, Wegner's granulomatosis)
- diabetes
- renal stones the last five years
- subjects seriously ill (or with chronic disease) and unfit for participation in the study (as judged by one of the study doctors)
- subjects using vitamin D supplements exceeding 800 IU per day or active vitamin D drugs (Rocaltrol or Etalpha)
- pregnancy
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：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 |
|---|---|
|
实验性的：vitamin D bolus
vitamin D 160 000 IU given as bolus
|
vitamin D given as bolus versus daily dosing
|
|
实验性的：vitamin D daily
vitamin D 4000 IU daily for 28 days
|
vitamin D given as bolus versus daily dosing
|
|
安慰剂比较：placebo
identical looking as vitamin d
|
identical looking as vitamin D
|
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 |
|---|---|---|
|
Hepcidin change
大体时间：4 weeks
|
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU regarding change in serum hepcidin
|
4 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Difference in serum PTH after 1 month
大体时间：4 weeks
|
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU regarding change in serum PTH, cathelicidin, RNA expression and micro RNA in peripheral blood, telomerase activity and the ratio between 1,25(OH)2D and 24,25(OH)2D, after 1 month
|
4 weeks
|
|
Difference in micro RNA Expression after 1 month
大体时间：4 weeks
|
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU
|
4 weeks
|
|
Difference in serum cathelicidin after 1 month
大体时间：4 weeks
|
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU
|
4 weeks
|
|
Difference in RNA Expression after 1 month
大体时间：4 weeks
|
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU
|
4 weeks
|
|
Difference in telomerase Activity after 1 month
大体时间：4 weeks
|
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU
|
4 weeks
|
|
Difference in ratio between 1,24(OH)2D and 24,24(OH)2D after 1 month
大体时间：4 weeks
|
Difference between vitamin D given as a bolus 160 000IU vs 4000 IU
|
4 weeks
|
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。
调查人员
- 首席研究员：rolf jorde, MD PhD、UiT, Tromsø
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 (实际的)
2017年12月1日
初级完成 (实际的)
2018年4月1日
研究完成 (实际的)
2018年5月1日
研究注册日期
首次提交
2017年6月15日
首先提交符合 QC 标准的
2017年9月1日
首次发布 (实际的)
2017年9月5日
研究记录更新
最后更新发布 (实际的)
2018年5月24日
上次提交的符合 QC 标准的更新
2018年5月23日
最后验证
2017年9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.
维生素D缺乏症的临床试验
-
University of UlsterAgri-Food and Biosciences Institute; Foodovation North West Regional College; Kenedy Bacon; Sofina... 和其他合作者邀请报名
-
Universitaire Ziekenhuizen KU LeuvenKU Leuven招聘中
-
University of UlsterNorthern Ireland Executive; HSC Public Health Agency完全的
-
University of UlsterDairy Council for Northern Ireland; Agri-food & Biosciences Institute; Center for Nutrition and...完全的
-
University of Eastern Finland完全的
-
University of Eastern FinlandDSM Nutritional Products, Inc.完全的
-
Meir Medical Center完全的开发从数字立体光盘图像测量 C/D 比的新技术 | C/D 测量的观察者内再现性 | C/D 测量的观察者间变异性
Vitamin D的临床试验
-
Héctor Iván Saldívar CerónUniversity of Illinois at Chicago尚未招聘
-
Johns Hopkins UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)完全的
-
GlaxoSmithKline完全的
-
Johns Hopkins UniversityNational Institute of Allergy and Infectious Diseases (NIAID)招聘中
-
Daewoong Pharmaceutical Co. LTD.完全的