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Study of High-Dose Oral Vitamin D for the Prevention of Liver Cancer

Primary Purpose

Cirrhosis, Hepatocellular Carcinoma

Status

Withdrawn

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Vitamin D

About this trial

This is an interventional other trial for Cirrhosis focused on measuring Vitamin D

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Sibley Memorial Hospital /Johns Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

Dose VD 1

Dose VD 2

Dose VD 3

Dose VD 4

Dose VD 5

VD 6 Month Treatment

Arm Description

Vitamin D

Outcomes

Primary Outcome Measures

Number of participants on high dose Vitamin D with adverse events

Secondary Outcome Measures

Changes in the expression of serum and imaging biomarkers

Full Information

NCT ID

NCT01956864

First Posted

September 30, 2013

Last Updated

January 30, 2018

Sponsor

Johns Hopkins University

Collaborators

M.D. Anderson Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT01956864

Brief Title

Study of High-Dose Oral Vitamin D for the Prevention of Liver Cancer

Official Title

A Phase I Study of High-Dose Oral Vitamin D for the Prevention of Hepatocellular Carcinoma in Subjects With Cirrhosis

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Withdrawn

Why Stopped

PI transferred from Georgetown to Johns Hopkins University. No participants enrolled at either site. Funding lapsed.

Study Start Date

September 2013 (Actual)

Primary Completion Date

February 11, 2016 (Actual)

Study Completion Date

February 11, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

Collaborators

M.D. Anderson Cancer Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cirrhosis, Hepatocellular Carcinoma

Keywords

Vitamin D

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dose VD 1

Arm Type

Experimental

Arm Description

Vitamin D

Arm Title

Dose VD 2

Arm Type

Experimental

Arm Description

Vitamin D

Arm Title

Dose VD 3

Arm Type

Experimental

Arm Description

Vitamin D

Arm Title

Dose VD 4

Arm Type

Experimental

Arm Description

Vitamin D

Arm Title

Dose VD 5

Arm Type

Experimental

Arm Description

Vitamin D

Arm Title

VD 6 Month Treatment

Arm Type

Experimental

Arm Description

Vitamin D

Intervention Type

Drug

Intervention Name(s)

Vitamin D

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of participants on high dose Vitamin D with adverse events

Time Frame

after 1 year

Secondary Outcome Measure Information:

Title

Changes in the expression of serum and imaging biomarkers

Time Frame

After 6 months on vitamin D regimen

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kirti Shetty, MD

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sibley Memorial Hospital /Johns Hopkins University

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

12. IPD Sharing Statement

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Study of High-Dose Oral Vitamin D for the Prevention of Liver Cancer

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