Effects of Vitamin D Status and Multiple Mega-dose Supplementation on Health Care Disparities in Perioperative Patients With Hepatocellular Carcinoma Receiving Hepatectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 120
- Primary Endpoint
- Whether there is an association between 25(OH)D and PTH: positive or negative association , or no association
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥ 20-year HCC subjects receiving laparoscopic hepatectomy
- •2.Sign the informed consent
Exclusion Criteria
- •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
Arms & Interventions
Placebo Group
Oral supplementation of placebo in 3 days
Intervention: Placebo (Other)
Vitamin D group
Oral supplementation of 1,728,000 IU vitamin D3 in 3 days
Intervention: Vitamin D (Other)
Outcomes
Primary Outcomes
Whether there is an association between 25(OH)D and PTH: positive or negative association , or no association
Time Frame: During the study period
Ratio of liver failure
Time Frame: 1 day before discharge
Ratio of liver failure
Time Frame: 1 day post- OP (day 1)
Ratio of liver failure
Time Frame: 7 days pre- OP (day -7)
Ratio of liver failure
Time Frame: 1 day pre- OP (day -1)
Secondary Outcomes
- 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)