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

NCT01956864 | Withdrawn Phase 1

• 1 other identifier: IRB00047888
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cirrhosis; Hepatocellular Carcinoma

Keywords

Vitamin D

Outcome Measures

Primary Outcomes (1)

• Number of participants on high dose Vitamin D with adverse events

  after 1 year

Secondary Outcomes (1)

• Changes in the expression of serum and imaging biomarkers

  After 6 months on vitamin D regimen

Study Arms (6)

Dose VD 1

EXPERIMENTAL

Vitamin D

Drug: Vitamin D

Dose VD 2

EXPERIMENTAL

Vitamin D

Drug: Vitamin D

Dose VD 3

EXPERIMENTAL

Vitamin D

Drug: Vitamin D

Dose VD 4

EXPERIMENTAL

Vitamin D

Drug: Vitamin D

Dose VD 5

EXPERIMENTAL

Vitamin D

Drug: Vitamin D

VD 6 Month Treatment

EXPERIMENTAL

Vitamin D

Drug: Vitamin D

Interventions

Vitamin D DRUG

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.

Dose VD 1; Dose VD 2; Dose VD 3; Dose VD 4; Dose VD 5; VD 6 Month Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• M.D. Anderson Cancer Center: collaborator

Study Sites (1)

Sibley Memorial Hospital /Johns Hopkins University

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Conditions

Fibrosis; Carcinoma, Hepatocellular

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Kirti Shetty, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2013
• First Posted: October 8, 2013
• Study Start: September 1, 2013
• Primary Completion: February 11, 2016
• Study Completion: February 11, 2016
• Last Updated: February 1, 2018

Record last verified: 2018-01

Locations

US (1)