Study of High-Dose Oral Vitamin D for the Prevention of L... | NCT01956864

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

NCT01956864

Sponsor

Johns Hopkins University

Status

Withdrawn

Last Update Posted

Feb 1, 2018Actual

Enrollment

0Actual

Phase

Phase 1

Conditions

Cirrhosis
Hepatocellular Carcinoma

Interventions

Vitamin D

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

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

Expanded Access Info

Start Date

Sep 2013Actual

Primary Completion Date

Feb 11, 2016Actual

Completion Date

Feb 11, 2016Actual

First Submitted Date

Sep 30, 2013

First Submission Date that Met QC Criteria

Sep 30, 2013

First Posted Date

Oct 8, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2018

Last Update Posted Date

Feb 1, 2018Actual

Name	Class
M.D. Anderson Cancer Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Measure	Description	Time Frame
Number of participants on high dose Vitamin D with adverse events		after 1 year

Measure	Description	Time Frame
Changes in the expression of serum and imaging biomarkers		After 6 months on vitamin D regimen

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D005355	Fibrosis
D006528	Carcinoma, Hepatocellular

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D000230	Adenocarcinoma
D002277	Carcinoma

ID	Term
D012632	Secosteroids
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds