Effects of Vitamin D Status and Multiple Mega-dose Supplementation on Health Care Disparities in Perioperative Patients With Hepatocellular Carcinoma Receiving Hepatectomy

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Vitamin D Status and Multiple Mega-dose Supplementation on Health Care Disparities in Perioperative Patients With Hepatocellular Carcinoma Receiving Hepatectomy

Conditions
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Hepatocellular Carcinoma, Liver Function, Postoperative Complications

Intervention / Treatment
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* Other: Vitamin D
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. ≥ 20-year HCC subjects receiving laparoscopic hepatectomy 2.Sign the informed consent Exclusion Criteria: 1. Using estrogen drugs, bisphosphonates, or drugs for bone disease. 2. Consume calcium tablets within 2 weeks before operation 3. Sarcoidosis, multiple myeloma 4. Pregnant women or plan to become pregnant within 3 months after surgery 5. Autoimmune hepatitis (AIH) 6. Early liver recurrence 7. Used to participate in other clinical trials

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D group<br>Oral supplementation of 1,728,000 IU vitamin D3 in 3 days | Other: Vitamin D<br>* Oral supplementation of 576,000IU/day vitamin D3 in 3 consecutive days<br>|
| Placebo Comparator: Placebo Group<br>Oral supplementation of placebo in 3 days | Other: Placebo<br>* Oral supplementation of placebo in 3 consecutive days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whether there is an association between 25(OH)D and PTH: positive or negative association , or no association |  | During the study period | 
| Ratio of liver failure |  | 7 days pre- OP (day -7) | 
| Ratio of liver failure |  | 1 day pre- OP (day -1) | 
| Ratio of liver failure |  | 1 day post- OP (day 1) | 
| Ratio of liver failure |  | 1 day before discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 hypercalcemia |  | 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 | Including level of C-reactive protein and white blood cell (WBC) count | day 1 post-OP and 1 day before discharge | 
| Complications after surgery | Including in-hospital infectious complications, Dindo-Clavien classification, volume of ascites, duration of ascites, intra-abdominal abscess, postoperative haemorrhage, pleural effusion, wall abscess, and eventration. | day 1 post-OP and 1 day before discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D Supplementation, Hepatectomy, Perioperative