Open Clinical Trial to Validate a Short-term Vitamin D Loading and Maintenance Dose Protocol in People With Advanced Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Plasma 25-hydroxyvitamin D concentration
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Vitamin D
vitamin D 20,000 IU per day for 2 weeks followed by 10,000 IU per day for a further 7 days
干预措施: vitamin D (Dietary Supplement)
结局指标
主要结局
Plasma 25-hydroxyvitamin D concentration
时间窗: 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
次要结局
- Mood(3 weeks)
- Symptoms(3 weeks)
研究者
John Hoffer
Professor of Medicine, McGill University
Jewish General Hospital