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NCT Number: NCT05887505

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

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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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Function Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Other

Oral supplementation of 576,000IU/day vitamin D3 in 3 consecutive days

Placebo

Other

Oral supplementation of placebo in 3 consecutive days.

Primary outcomes

  1. Whether there is an association between 25(OH)D and PTH: positive or negative association , or no association

    Time frame: During the study period

  2. Ratio of liver failure

    Time frame: 7 days pre- OP (day -7)

  3. Ratio of liver failure

    Time frame: 1 day pre- OP (day -1)

  4. Ratio of liver failure

    Time frame: 1 day post- OP (day 1)

  5. Ratio of liver failure

    Time frame: 1 day before discharge

Secondary outcomes

  1. 25(OH)D status

    Time frame: Baseline (day -7), day -1, day 1 and 1 day before discharge

  2. Prevalence of high PTH

    Time frame: Baseline (day -7), day -1, day 1 and 1 day before discharge

  3. Prevalence of hypercalcemia

    Time frame: Baseline (day -7), day -1, day 1 and 1 day before discharge

  4. Prevalence of hypomagnesemia

    Time frame: Baseline (day -7), day -1, day 1 and 1 day before discharge

  5. 30-day mortality

    Time frame: day 1 post-OP and 1 day before discharge

  6. Clinical outcomes

    Time frame: day 1 post-OP and 1 day before discharge

    Including level of C-reactive protein and white blood cell (WBC) count

  7. Complications after surgery

    Time frame: day 1 post-OP and 1 day before discharge

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yuan-Hao Ku, MD

CONTACT

[email protected]

+886-3 3699721 ext. 4208

Sponsors and collaborators

Lead sponsor

Taoyuan General Hospital

Other Gov

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 2, 2023
Registry last updated
Jun 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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