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

• Status: Withdrawn
• Trial end date: 2016-02-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: M.D. Anderson Cancer Center
• Treatments: Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

1. 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.

2. No evidence of HCC on entry imaging study ( if liver nodules are present, these should be classified as LIRADS 1-3 only).

3. 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%).

4. Not currently participating in another intervention study.

5. Not pregnant or lactating, and willing to use effective contraception during study period.

6. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

7. Ability to provide written informed consent according to national/local regulations

Exclusion Criteria:

1. Any diagnosis of kidney stones

2. 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

3. A diagnosis of hyperparathyroidism or other serious disturbance of calcium metabolism in the past 5 years

4. A diagnosis of severe kidney disease, e.g., chronic renal failure, in the past 6 months

5. A diagnosis of unexplained hypercalcemia in the past 6 months

6. Any diagnosis of osteoporosis with physician recommendation for treatment of low bone mass

7. A diagnosis of two or more low trauma fractures in the past 6 months

8. A diagnosis of a medical condition requiring treatment with VD (e.g., osteomalacia) in the past 6 months