CirrhosisPhase 1NCT01956864
Study of High-Dose Oral Vitamin D for the Prevention of Liver Cancer
A Phase 1 study testing Vitamin D in people with Cirrhosis and Hepatocellular Carcinoma, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of a high dose of vitamin D (VD) in patients with cirrhosis. The investigator hypothesizes that high dose VD will be safe and well-tolerated in adults with cirrhosis, and will inhibit the inflammatory and proliferative events that cause progression… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cirrhosis, Hepatocellular Carcinoma
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to 11 Feb 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects between the ages of 18 and 75 with cirrhosis of any etiology followed at the Georgetown Transplant Institute, Washington, DC, will be offered entry into this study. The diagnosis of cirrhosis will be based on clinical, imaging or histological studies.
- No evidence of HCC on entry imaging study ( if liver nodules are present, these should be classified as LIRADS 1-3 only).
- Model for End Stage Liver Disease (MELD) score under 22 (a MELD score over 22 would predict a 3 month mortality rate of approximately 20%).
- Not currently participating in another intervention study.
- Not pregnant or lactating, and willing to use effective contraception during study period.
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- Ability to provide written informed consent according to national/local regulations
Who cannot join
- Any diagnosis of kidney stones
- A diagnosis of granulomatous diseases (e.g., sarcoidosis), active chronic fungal or mycobacterial infections (e.g., tuberculosis, histoplasmosis, coccidioidomycosis, blastomycosis, berylliosis, or Wegener's granulomatosis) in the past 6 months
- A diagnosis of hyperparathyroidism or other serious disturbance of calcium metabolism in the past 5 years
- A diagnosis of severe kidney disease, e.g., chronic renal failure, in the past 6 months
- A diagnosis of unexplained hypercalcemia in the past 6 months
- Any diagnosis of osteoporosis with physician recommendation for treatment of low bone mass
- A diagnosis of two or more low trauma fractures in the past 6 months
- A diagnosis of a medical condition requiring treatment with VD (e.g., osteomalacia) in the past 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Sibley Memorial Hospital /Johns Hopkins University
Washington D.C., District of Columbia, 20007
About this study
Official title: A Phase I Study of High-Dose Oral Vitamin D for the Prevention of Hepatocellular Carcinoma in Subjects With Cirrhosis
The purpose of this study is to evaluate the safety and tolerability of a high dose of vitamin D (VD) in patients with cirrhosis. The investigator hypothesizes that high dose VD will be safe and well-tolerated in adults with cirrhosis, and will inhibit the inflammatory and proliferative events that cause progression of cirrhosis to hepatocellular carcinoma.
Read the detailed description
This study will be done in two phases. The first phase is being done to find the highest dose of VD that can be tolerated, in other words taken without causing severe side effects. The second phase is a 6 month treatment with the dose determined to be safe in the first phase, to investigate general health benefits and the potential to reduce the development of Hepatocellular carcinoma (HCC), also known as liver cancer. Improvement of general health will be determined by interviews with patients, markers in the blood for response to VD, bone remodeling, inflammation, and evidence of HCC on routine imaging.
- Conditions
- Cirrhosis, Hepatocellular Carcinoma
- Being tested
- Vitamin D
- Keywords
- Vitamin D
- Medical subject headings
- Fibrosis, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Doses of vitamin D will be increased from a baseline dose to the maximum tolerated dose. There could therefore be up to 5 possible doses of Vitamin D. Once the maximum tolerated dose of vitamin D has been determined, patients will follow a regimen on that dose for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Dose VD 1 | Experimental | Vitamin D Receives: Drug: Vitamin D |
| Dose VD 2 | Experimental | Vitamin D Receives: Drug: Vitamin D |
| Dose VD 3 | Experimental | Vitamin D Receives: Drug: Vitamin D |
| Dose VD 4 | Experimental | Vitamin D Receives: Drug: Vitamin D |
| Dose VD 5 | Experimental | Vitamin D Receives: Drug: Vitamin D |
| VD 6 Month Treatment | Experimental | Vitamin D Receives: Drug: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants on high dose Vitamin D with adverse events
Measured: after 1 year
Secondary outcomes (1)
Changes in the expression of serum and imaging biomarkers
Measured: After 6 months on vitamin D regimen
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startSep 2013
- Primary completion11 Feb 2016
- Study completion11 Feb 2016
Why it stopped: PI transferred from Georgetown to Johns Hopkins University. No participants enrolled at either site. Funding lapsed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- M.D. Anderson Cancer Center
- Responsible party
- Sponsor
- Investigators
- Kirti Shetty, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956864
- Sponsor's protocol ID
- IRB00047888
- Status last verified
- Jan 2018
- First submitted
- 30 Sep 2013
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of High-Dose Oral Vitamin D for the Prevention of Hepatocellular Carcinoma in Subjects With Cirrhosis
- ClinicalTrials.gov ID
- NCT01956864
- Acronym / sponsor ID
- IRB00047888
- Conditions
- Cirrhosis, Hepatocellular Carcinoma
- Keywords
- Vitamin D
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI transferred from Georgetown to Johns Hopkins University. No participants enrolled at either site. Funding lapsed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- M.D. Anderson Cancer Center
- Study start
- Sep 2013 (actual)
- Primary completion
- 11 Feb 2016 (actual)
- Study completion
- 11 Feb 2016 (actual)
- First posted
- 8 Oct 2013 (estimated)
- 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.
The purpose of this study is to evaluate the safety and tolerability of a high dose of vitamin D (VD) in patients with cirrhosis. The investigator hypothesizes that high dose VD will be safe and well-tolerated in adults with cirrhosis, and will inhibit the inflammatory and proliferative events that cause progression of cirrhosis to hepatocellular carcinoma.
Detailed description
This study will be done in two phases. The first phase is being done to find the highest dose of VD that can be tolerated, in other words taken without causing severe side effects. The second phase is a 6 month treatment with the dose determined to be safe in the first phase, to investigate general health benefits and the potential to reduce the development of Hepatocellular carcinoma (HCC), also known as liver cancer. Improvement of general health will be determined by interviews with patients, markers in the blood for response to VD, bone remodeling, inflammation, and evidence of HCC on routine imaging.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Dose VD 1 | Experimental | Drug: Vitamin DVitamin D |
| Dose VD 2 | Experimental | Drug: Vitamin DVitamin D |
| Dose VD 3 | Experimental | Drug: Vitamin DVitamin D |
| Dose VD 4 | Experimental | Drug: Vitamin DVitamin D |
| Dose VD 5 | Experimental | Drug: Vitamin DVitamin D |
| VD 6 Month Treatment | Experimental | Drug: Vitamin DVitamin D |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- All subjects between the ages of 18 and 75 with cirrhosis of any etiology followed at the Georgetown Transplant Institute, Washington, DC, will be offered entry into this study. The diagnosis of cirrhosis will be based on clinical, imaging or histological studies.
- No evidence of HCC on entry imaging study ( if liver nodules are present, these should be classified as LIRADS 1-3 only).
- Model for End Stage Liver Disease (MELD) score under 22 (a MELD score over 22 would predict a 3 month mortality rate of approximately 20%).
- Not currently participating in another intervention study.
- Not pregnant or lactating, and willing to use effective contraception during study period.
Key exclusion criteria (8 listed)
- Any diagnosis of kidney stones
- A diagnosis of granulomatous diseases (e.g., sarcoidosis), active chronic fungal or mycobacterial infections (e.g., tuberculosis, histoplasmosis, coccidioidomycosis, blastomycosis, berylliosis, or Wegener's granulomatosis) in the past 6 months
- A diagnosis of hyperparathyroidism or other serious disturbance of calcium metabolism in the past 5 years
- A diagnosis of severe kidney disease, e.g., chronic renal failure, in the past 6 months
- A diagnosis of unexplained hypercalcemia in the past 6 months
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 DDoses of vitamin D will be increased from a baseline dose to the maximum tolerated dose. There could therefore be up to 5 possible doses of Vitamin D. Once the maximum tolerated dose of vitamin D has been determined, patients will follow a regimen on that dose for 6 months. | Drug | Dose VD 1, Dose VD 2, Dose VD 3, Dose VD 4, Dose VD 5, VD 6 Month Treatment |
Primary outcome
Number of participants on high dose Vitamin D with adverse events
Time frame: after 1 year
1 secondary outcome
Changes in the expression of serum and imaging biomarkers
Time frame: After 6 months on vitamin D regimen
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
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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. This study is not recruiting at the moment.
Kirti Shetty, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vitamin D in people with Cirrhosis and Hepatocellular Carcinoma, run by Johns Hopkins University at 1 site in United States.
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 7 inclusion and 8 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: withdrawn, as of the sponsor's last update on 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants on high dose Vitamin D with adverse events (time frame: after 1 year). 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 1 Feb 2018.