Hepatocellular CarcinomaNCT05887505
Effects of Vitamin D Status and Multiple Mega-dose Supplementation on Health Care Disparities in Perioperative Patients With Hepatocellular Carcinoma Receiving Hepatectomy
A study testing Vitamin D in people with Hepatocellular Carcinoma and Liver Function, run by Taoyuan General Hospital.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Liver Function, Postoperative Complications
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 9 Jun 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. ≥ 20-year HCC subjects receiving laparoscopic hepatectomy
- 2.Sign the informed consent
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Being tested
- Vitamin D, Placebo
- Keywords
- Vitamin D Supplementation, Hepatectomy, Perioperative
- Medical subject headings
- Carcinoma, Hepatocellular, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DOther
Oral supplementation of 576,000IU/day vitamin D3 in 3 consecutive days
PlaceboOther
Oral supplementation of placebo in 3 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D group | Experimental | Oral supplementation of 1,728,000 IU vitamin D3 in 3 days Receives: Other: Vitamin D |
| Placebo Group | Placebo comparator | Oral supplementation of placebo in 3 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether there is an association between 25(OH)D and PTH: positive or negative association , or no association
Measured: During the study period
Ratio of liver failure
Measured: 7 days pre- OP (day -7)
Ratio of liver failure
Measured: 1 day pre- OP (day -1)
Ratio of liver failure
Measured: 1 day post- OP (day 1)
Ratio of liver failure
Measured: 1 day before discharge
Secondary outcomes (7)
25(OH)D status
Measured: Baseline (day -7), day -1, day 1 and 1 day before discharge
Prevalence of high PTH
Measured: Baseline (day -7), day -1, day 1 and 1 day before discharge
Prevalence of hypercalcemia
Measured: Baseline (day -7), day -1, day 1 and 1 day before discharge
Prevalence of hypomagnesemia
Measured: Baseline (day -7), day -1, day 1 and 1 day before discharge
30-day mortality
Measured: day 1 post-OP and 1 day before discharge
Clinical outcomes
Including level of C-reactive protein and white blood cell (WBC) count
Measured: 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.
Measured: day 1 post-OP and 1 day before discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start9 Jun 2023 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taoyuan General Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887505
- Sponsor's protocol ID
- TYGH111086
- Status last verified
- Apr 2023
- First submitted
- 2 May 2023
- Last updated
- 6 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vitamin D Status and Multiple Mega-dose Supplementation on Health Care Disparities in Perioperative Patients With Hepatocellular Carcinoma Receiving Hepatectomy
- ClinicalTrials.gov ID
- NCT05887505
- Acronym / sponsor ID
- TYGH111086
- Keywords
- Vitamin D Supplementation, Hepatectomy, Perioperative
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Taoyuan General HospitalOther government
- Study start
- 9 Jun 2023 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D group | Experimental | Other: Vitamin DOral supplementation of 1,728,000 IU vitamin D3 in 3 days |
| Placebo Group | Placebo comparator | Other: PlaceboOral supplementation of placebo in 3 days |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. ≥ 20-year HCC subjects receiving laparoscopic hepatectomy
- 2.Sign the informed consent
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DOral supplementation of 576,000IU/day vitamin D3 in 3 consecutive days | Other | Vitamin D group |
| PlaceboOral supplementation of placebo in 3 consecutive days. | Other | Placebo Group |
Primary outcome
Whether there is an association between 25(OH)D and PTH: positive or negative association , or no association
Time frame: During the study period
Ratio of liver failure
Time frame: 7 days pre- OP (day -7)
Ratio of liver failure
Time frame: 1 day pre- OP (day -1)
Ratio of liver failure
Time frame: 1 day post- OP (day 1)
Ratio of liver failure
Time frame: 1 day before discharge
7 secondary outcomes
25(OH)D status
Time frame: Baseline (day -7), day -1, day 1 and 1 day before discharge
Prevalence of high PTH
Time frame: Baseline (day -7), day -1, day 1 and 1 day before discharge
Prevalence of hypercalcemia
Time frame: Baseline (day -7), day -1, day 1 and 1 day before discharge
Prevalence of hypomagnesemia
Time frame: Baseline (day -7), day -1, day 1 and 1 day before discharge
30-day mortality
Time frame: day 1 post-OP and 1 day before discharge
Clinical outcomes
Time frame: day 1 post-OP and 1 day before discharge
Complications after surgery
Time frame: day 1 post-OP and 1 day before discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Hepatocellular Carcinoma and Liver Function, run by Taoyuan General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuan-Hao Ku, MD (+886-3 3699721 ext. 4208, darkbravo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whether there is an association between 25(OH)D and PTH: positive or negative association , or no association (time frame: During the study period). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2023.