Effects of Vitamin D Status and Multiple Mega-dose Supplementation on Health Care Disparities in Perioperative Patients With Hepatocellular Carcinoma Receiving Hepatectomy
1 other identifier
interventional
120
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hepatocellular-carcinoma
Started Jun 2023
Typical duration for not_applicable hepatocellular-carcinoma
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2023
CompletedFirst Posted
Study publicly available on registry
June 2, 2023
CompletedStudy Start
First participant enrolled
June 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
June 6, 2023
April 1, 2023
4.5 years
May 2, 2023
June 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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 Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (2)
Vitamin D group
EXPERIMENTALOral supplementation of 1,728,000 IU vitamin D3 in 3 days
Placebo Group
PLACEBO COMPARATOROral supplementation of placebo in 3 days
Interventions
Eligibility Criteria
You may qualify if:
- \. ≥ 20-year HCC subjects receiving laparoscopic hepatectomy
- Sign the informed consent
You may not qualify if:
- \. 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 2, 2023
First Posted
June 2, 2023
Study Start
June 9, 2023
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
June 6, 2023
Record last verified: 2023-04