NCT01045109已完成2 期
Vitamin D and Prostate Cancer
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Effect of vitamin D3 supplementation on prostate specific antigen levels in patients diagnosed with early stage, low-grade, low-risk prostate cancer.
研究概览
简要总结
This clinical trial is aimed at measuring the effect of vitamin D3 supplementation on serum prostate-specific antigen (PSA) levels in patients diagnosed with early stage, low-grade, low-risk prostate cancer (Gleason score less than/equal to 6; PSA less than/equal to 10; clinical stage T1C or T2a), who elect to have their disease monitored through active surveillance for at least one year.
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 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •lowgrade prostate cancer
- •serum PSA less than/equal to 10 ng/ml
- •Gleason score less than/equal to 6
- •referred from their treating physician with treatment plan of active surveillance for one year
- •serum creatinine less than/equal to 2.0 mg/dL
- •serum phosphate (measured as phosphorus)greater than 2.3 and less than 4.8 mg/dL
- •serum calcium greater than 8.5 and less than 10.5 mg/dL
排除标准
- •concurrent malignancy, except non-melanoma skin cancer
- •history of sarcoidosis
- •history of high dose (greater than 1,000 IU daily) vitamin D3 supplementation
- •history of hypercalcemia
- •treatment with lithium medication
研究组 & 干预措施
open-label vitamin D3
Experimental
One arm: open-label receiving vitamin D3 4,000 IU daily
干预措施: cholecalciferol (Dietary Supplement)
结局指标
主要结局
Effect of vitamin D3 supplementation on prostate specific antigen levels in patients diagnosed with early stage, low-grade, low-risk prostate cancer.
时间窗: 48 weeks
次要结局
- Safety of subjects (determined by safety lab values every 8 weeks: serum Creatinine, Ca, Phosphorus, PTH, vit D3; CBC with differential; and urine Ca/Creat ratio) taking vitamin D3 supplementation (4,000 I.U.) daily.(48 weeks)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Vitamin D in Treating Patients With Prostate CancerProstate CancerNCT00524680Roswell Park Cancer Institute148
已完成
2 期
Vitamin D3 Supplementation for Low-Risk Prostate Cancer: A Randomized TrialProstate CancerNCT01759771VA Office of Research and Development130
已完成
2 期
Clinical Trial of Vitamin D3 to Reduce Cancer Risk in Postmenopausal WomenCancerNCT01052051Creighton University2,303
已完成
2 期
Vitamin D and Prostate Cancer: A Clinical Study Enrolling Subjects Undergoing ProstatectomyProstate CancerNCT02726113Medical University of South Carolina50
已完成
1 期
Calcitriol and Zoledronate in Treating Patients With Progressive Prostate CancerProstate CancerNCT00004928Memorial Sloan Kettering Cancer Center