Influence of High Dose Vitamin D3 Intake on Outcome in Pancreatic Cancer Surgery: Prospective, Randomized, Open, Controlled Pilot Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- 25(OH) vitamin D
研究概览
简要总结
Different studies have shown that a deficiency in vitamin D (≤20ng/mL) results in higher rates in morbidity and mortality rates in cancer patients. Clinical studies investigated and demonstrated altered vitamin d tissue in pancreatic cancer. But there is no prospective study evaluating the beneficiary effects of oral supplementation of vitamin d in altered vitamin d tissue from pancreatic cancer. We want to examine the effect of a high dose vitamin D3 therapy vs. a standard base dose vitamin D3 therapy in pancreas cancer patients with a vitamin D deficiency. In case of benefit in our results we could implement vitamin D3 as a supportive standard therapy in pancreatic cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •vitamin D deficiency(≤20ng/ml)
- •patients>18 years of age
- •pancreatic cancer
- •surgical intervention/non-surgical intervention
- •signed written informed consent
排除标准
- •patients<18 years of age
- •pregnancy
- •contraindication for oral vitamin D intake
- •hypercalcemia (> 2.65 mmol/l total calcium and/or > 1.35 mmol/l ionized calcium at screening)
- •other ongoing vitamin D conducted trial
- •known kidney stones, active tuberculosis or sarcoidosis (in the last 12 months)
- •metastasized pancreatic cancer
- •normal vitamin D serum levels
- •missing written informed consent
研究组 & 干预措施
High-dose
Intervention with high dose oral vitamin D3 supplementation.
1 drop equals 400 I.U. This group will get 180.000 I.U. on day 1, and then 4000 I.U. per day for 60 days.
干预措施: High-dose (Drug)
Standard-dose
Intervention with standard dose oral vitamin D3 supplementation.
1 drop equals 400 I.U. This group will get 800 I.U. per day for 60 days.
干预措施: Standard dose (Drug)
结局指标
主要结局
25(OH) vitamin D
时间窗: Day 60
Blood level of Vitamin D3
次要结局
- hospital stay(Day 60)
- 1,25(OH)2D vitamin D(Day 60)
- Urine Calcium(Day 60)
- 60-day mortality(Day 60)
- hospital readmission(Day 60)
- 25(OH) vitamin D(Day 30)
- Beta-crosslaps(Day 60)
- Calcium(Day 30)
- creatinine(Day 60)
- Osteocalcin(Day 60)
- ionized calcium(Day 60)
- phosphate(Day 30)
- hepcidin(Day 60)
- Quality of Life questionnaire(Day 60)