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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05887505
• Other study ID #: TYGH111086
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 9, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: April 2023
• Source: Taoyuan General Hospital
• Contact: Yuan-Hao Ku, MD
• Phone: +886-3 3699721
• Email: darkbravo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 31, 2027
• Est. primary completion date: December 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Liver Function
• Postoperative Complications

Intervention

Other:
• Vitamin D
Oral supplementation of 576,000IU/day vitamin D3 in 3 consecutive days
• Placebo
Oral supplementation of placebo in 3 consecutive days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taoyuan General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whether there is an association between 25(OH)D and PTH: positive or negative association , or no association		During the study period
Primary	Ratio of liver failure		7 days pre- OP (day -7)
Primary	Ratio of liver failure		1 day pre- OP (day -1)
Primary	Ratio of liver failure		1 day post- OP (day 1)
Primary	Ratio of liver failure		1 day before discharge
Secondary	25(OH)D status		Baseline (day -7), day -1, day 1 and 1 day before discharge
Secondary	Prevalence of high PTH		Baseline (day -7), day -1, day 1 and 1 day before discharge
Secondary	Prevalence of hypercalcemia		Baseline (day -7), day -1, day 1 and 1 day before discharge
Secondary	Prevalence of hypomagnesemia		Baseline (day -7), day -1, day 1 and 1 day before discharge
Secondary	30-day mortality		day 1 post-OP and 1 day before discharge
Secondary	Clinical outcomes	Including level of C-reactive protein and white blood cell (WBC) count	day 1 post-OP and 1 day before discharge
Secondary	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