Effects of Vitamin D Status and Multiple Mega-dose Supplementation on Health Care Disparities in Perioperative Patients With Hepatocellular Carcinoma Receiving Hepatectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- Whether there is an association between 25(OH)D and PTH: positive or negative association , or no association
研究概览
简要总结
High concentrations of parathyroid hormone (PTH) are common in patients with hepatocellular carcinoma (HCC). This study is aimed to investigate effects of vitamin D status and its multiple mega-dosage supplementation on PTH and clinical outcomes in HCC patients before and after hepatectomy. It's a single-center, prospective, parallel, double-blind, placebo-controlled study for 120 eligible subjects. The subjects will receive consecutively 3-day intervention treatments from 7th day before surgery. 30-day postoperative mortality, postoperative complications, and laboratory data will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 20-year HCC subjects receiving laparoscopic hepatectomy
- •2.Sign the informed consent
排除标准
- •Using estrogen drugs, bisphosphonates, or drugs for bone disease.
- •Consume calcium tablets within 2 weeks before operation
- •Sarcoidosis, multiple myeloma
- •Pregnant women or plan to become pregnant within 3 months after surgery
- •Autoimmune hepatitis (AIH)
- •Early liver recurrence
- •Used to participate in other clinical trials
研究组 & 干预措施
Placebo Group
Oral supplementation of placebo in 3 days
干预措施: Placebo (Other)
Vitamin D group
Oral supplementation of 1,728,000 IU vitamin D3 in 3 days
干预措施: Vitamin D (Other)
结局指标
主要结局
Whether there is an association between 25(OH)D and PTH: positive or negative association , or no association
时间窗: During the study period
Ratio of liver failure
时间窗: 1 day before discharge
Ratio of liver failure
时间窗: 1 day post- OP (day 1)
Ratio of liver failure
时间窗: 7 days pre- OP (day -7)
Ratio of liver failure
时间窗: 1 day pre- OP (day -1)
次要结局
- Complications after surgery(day 1 post-OP and 1 day before discharge)
- 25(OH)D status(Baseline (day -7), day -1, day 1 and 1 day before discharge)
- Prevalence of high PTH(Baseline (day -7), day -1, day 1 and 1 day before discharge)
- Prevalence of hypomagnesemia(Baseline (day -7), day -1, day 1 and 1 day before discharge)
- 30-day mortality(day 1 post-OP and 1 day before discharge)
- Clinical outcomes(day 1 post-OP and 1 day before discharge)
- Prevalence of hypercalcemia(Baseline (day -7), day -1, day 1 and 1 day before discharge)