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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D group | Experimental | Oral supplementation of 1,728,000 IU vitamin D3 in 3 days |
|
| Placebo Group | Placebo Comparator | Oral supplementation of placebo in 3 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Other | Oral supplementation of 576,000IU/day vitamin D3 in 3 consecutive days |
| |
| 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 |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuan-Hao Ku, MD | Contact | +886-3 3699721 | 4208 | darkbravo@gmail.com |
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| Placebo |
| Other |
Oral supplementation of placebo in 3 consecutive days. |
|
| 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 |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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