Vitamin D Loading Dose in Advanced Lung Cancer
Open Clinical Trial to Validate a Short-term Vitamin D Loading and Maintenance Dose Protocol in People With Advanced Lung Cancer
Hypovitaminosis D is highly prevalent in people with lung cancer, and may have adverse clinical consequences. The long and variable pharmacokinetic half-life of vitamin D makes prompt vitamin D replacement problematic. This is an open, one-armed therapeutic intervention using a loading dose of vitamin D that will be predicted to increase plasma 25-hydroxyvitamin D concentrations of every patient well into the normal range (> 100 nmol/L) within 2 or 3 weeks and monitored after 2 and 3 weeks of loading and maintenance dose. Preliminary data will also be obtained to identify potentially clinical important outcome benefits for future investigation. The outcomes are
- plasma 25OHD concentration
- Vitamin D binding protein and other plasma concentrations
- Mood and symptom
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
-
-
Quebec
-
Montreal、Quebec、加拿大、H3T 1E2
- Brojde Lung Cancer Centre, Jewish General Hospital
-
-
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:
- Any patient with advanced lung cancer whether or not receiving specific anti-cancer therapy
- Mentally competent (but need not be fluent in French or English if capable neutral translator available)
- Self report of reduced food intake and/or involuntary weight loss of any extent at time of enrollment: does not have to be documented
Exclusion Criteria:
- Current diagnosis of primary hyperparathyroidism
- Nephrocalcinosis
- Current or suspected active tuberculosis, histoplasmosis, sarcoidosis, or other granulomatous disease
- Current using a vitamin D supplement providing > 1000 IU/day
- Current prescribed calcitriol in any dose
- History of extensive sunlight exposure (> 30 min summer sunlight exposure per day for more than 5 days per week) in previous 3 months
- Expected to die within next 2 months
- Pregnancy
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Vitamin D
vitamin D 20,000 IU per day for 2 weeks followed by 10,000 IU per day for a further 7 days
|
vitamin D3 20,000 IU per day for 14 days followed by 10,000 IU per day for a further 7 days
|
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 |
|---|---|---|
|
Plasma 25-hydroxyvitamin D concentration
大体时间：3 weeks
|
Plasma 25OHD concentration measured within 24 h prior to commencing vitamin D therapy, and again after 14 and 21 days of continuous vitamin D therapy
|
3 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mood
大体时间：3 weeks
|
Two validated brief mood assessment questionnaires measured
|
3 weeks
|
|
Symptoms
大体时间：3 weeks
|
As with mood questionnaire, a symptom questionnaire (Edmonton Symptom Assessment System) will be administered two times (one week apart) prior to starting vitamin therapy and after 14 and 21 days of continuous vitamin D administration
|
3 weeks
|
合作者和调查者
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 (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.