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

NCT01956864 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2018-02-01

No results posted yet for this study

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

Interventions

DRUG

Vitamin D

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.

Sponsors & Collaborators

Principal Investigators

  • Kirti Shetty, MD · Johns Hopkins University

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2016-02-11
Completion
2016-02-11

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01956864 on ClinicalTrials.gov