Vitamin D Levels in Stage IV Colorectal Cancer Patients: A Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 5
- 主要终点
- To Achieve Target Vitamin D Level
研究概览
简要总结
The purpose of this study is to find out what effects, good and/or bad, vitamin D blood levels has on stage IV colorectal cancer. Tbe doctors want to see if it is possible to increase low vitamin D levels into normal range using vitamin D supplements taken by mouth. Low vitamin D levels have been associated with worse outcomes in persons who have cancer. Low vitamin D may also cause people to have symptoms such as pain and fatigue. We want to see if increasing low vitamin D levels will help improve cancer outcomes. Vitamin D is routinely repleted in all subjects known to be vitamin D deficient. Therefore, the treatment given would be considered standard of care.
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
- •Patients with Stage IV (metastatic) colorectal cancer
- •Baseline 25-hydroxy vitamin D level < 30 ng/ml
- •Age ≥18 years of age
排除标准
- •Current or previous malignancy except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for > 3 years
- •Albumin < 3.2
- •Patients on concurrent chronic steroids, other than those allowed for routine antiemetics, or inhaled steroids
- •Patients receiving phenobarbital, phenytoin, orlistat and cholestyramine
- •Hypercalcemia (Calcium >10.5 mg/dl)
- •Calcium x Phosphorus > 70 mg2/dL2
研究组 & 干预措施
vitamin D, vitamin D3
This is a Phase II study involving Stage IV colorectal cancer patients with serum vitamin D deficiency, to determine the ability to correct vitamin D deficiency and to maintain serum vitamin D levels (25-hydroxy vitamin D) once achieved.
干预措施: vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) (Drug)
结局指标
主要结局
To Achieve Target Vitamin D Level
时间窗: Within 6 weeks of beginning vitamin D
To determine the ability of achieving the target serum 25-hydroxy vitamin D level of 40 ng/ml within 6 weeks of beginning vitamin D supplements in patients with metastatic colon cancer. A response is defined as achieving serum vitamin D levels ≥40 ng/ml at least once at any point during the first 6 weeks
次要结局
未报告次要终点