High Dose Vitamin D Study
Study of High-dose Vitamin D Supplementation in Stage-4 Colorectal Cancer Patients
The purpose of this study is to investigate the therapeutic effect and the safety of high-dose vitamin D supplementation in metastatic colorectal cancer patients. We propose to supplement metastatic (stage 4) colorectal cancer patients with oral doses of vitamin D to raise serum 25-hydroxy-vitamin D [25(OH)D] levels to the high normal range of 200-250 nmol/L. The primary objective of this study is to evaluate the metabolic consequences, including tolerability and toxicity, of prolonged, high-dose physiological vitamin D in patients with colorectal cancer. The secondary objective is to evaluate patient survival with regards to high-dose vitamin D supplementation.
Hypothesis:
Whereas low doses of vitamin D reportedly play a significant role in prevention of colorectal cancers, do much larger (pharmacological) doses of vitamin D have a significant therapeutic effect against the same kind of cancer?
研究概览
详细说明
研究类型
注册 (预期的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习地点
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British Columbia
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Vancouver、British Columbia、加拿大、V6H 4A6
- InspireHealth
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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 (We will recruit stage 4 (metastatic) colorectal cancer patients who are clients at InspireHealth):
- Age > 18
- Histologically confirmed colon or rectal cancer
- Known metastatic disease (stage-4) confirmed histologically or radiologically
- Life expectancy of >8 months
- May receive anti-neoplastic therapy at the discretion of their physician
- Stable metastatic disease defined as no change in systemic for the month before and the month after commencing study
- Signed informed consent
Exclusion Criteria(Stage 4 colorectal cancer patients):
- Pregnant / lactating women
- Known hypersensitivity to vitamin D
- Pre-existing renal stone disease based on history
- Pre-existing hypercalcemia
- Severe renal or hepatic dysfunction (≥ 2x of the upper normal range)
- granulomatous disease (TB and sarcoid)
- unable to give informed consent in English (translations of study documents in languages other than English will not be provided)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：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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无干预：无干预
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实验性的：Experimental Dietary Supplement (e.g., vitamins, minerals)
Experimental arm is supplemented with high-dose of vitamin D.
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We propose to study high-dose, oral vitamin D supplementation, raising serum 25-hydroxy-vitamin D (25(OH)D) concentrations to 200 -250 nmol/L, in metastatic colorectal cancer patients with safety, tolerability and survival as the main outcome measurements.
The dose is not pre-set and will depend on the individual subjects' serum 25(OH)D concentration.
Subjects will be supplemented for 16 months with a daily oral dose, followed by a 12 months follow-up period.
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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 |
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The metabolic consequences, including tolerability and toxicity, of prolonged, high-dose physiological vitamin D in patients with colorectal cancer.
大体时间：After 16 months of intervention
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After 16 months of intervention
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The metabolic consequences, including tolerability and toxicity, of prolonged, high-dose physiological vitamin D in patients with colorectal cancer.
大体时间：After 12 months of follow-up
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After 12 months of follow-up
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Patient survival with regards to high-dose vitamin D supplementation.
大体时间：After 16 months of intervention
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After 16 months of intervention
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Patient survival with regards to high-dose vitamin D supplementation.
大体时间：After 12 months of follow-up
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After 12 months of follow-up
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合作者和调查者
调查人员
- 首席研究员：Hal Gunn, MD、University of British Columbia
出版物和有用的链接
有用的网址
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 (实际的)
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