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The Effect of Vitamin D Repletion in Patients With Hepatocellular Carcinoma on the Orthotopic Liver Transplant List

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01575717
Recruitment Status : Unknown
Verified October 2012 by Andrea Branch, Icahn School of Medicine at Mount Sinai.
Recruitment status was:  Recruiting
First Posted : April 11, 2012
Last Update Posted : October 24, 2012
Sponsor:
Information provided by (Responsible Party):
Andrea Branch, Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE April 9, 2012
First Posted Date  ICMJE April 11, 2012
Last Update Posted Date October 24, 2012
Study Start Date  ICMJE January 2012
Estimated Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2012)
Change in serum levels of 25-hydroxyvitamin D [ Time Frame: at baseline, and at 3 and 6 months ]
Change in serum levels of 25-hydroxyvitamin D at 3 months and 6 months compared to baseline
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2012)
  • Change in serum levels of liver enzymes (ALT, AST and Alk phos) [ Time Frame: at baseline, and at 3 and 6 months ]
    Change in serum levels of liver enzymes (ALT, AST and Alk phos) at 3 months and at 6 months compared to baseline
  • Change in serum creatinine [ Time Frame: at baseline, and at 3 and 6 months ]
    Change in serum creatinine at 3 months and at 6 months compared to baseline
  • Serum Calcium [ Time Frame: at 3 months ]
  • Serum Calcium [ Time Frame: at 6 months ]
  • Change in coagulation profile (PT/PTT and INR) [ Time Frame: at baseline, and at 3 and 6 months ]
    Change in coagulation profile (PT/PTT and INR) at 3 months and at 6 months compared to baseline
  • Change in Model for End stage Liver Disease score (MELD) [ Time Frame: at baseline, and at 3 and 6 months ]
    Change in Model for End stage Liver Disease score (MELD) at 3 months and at 6 months compared to baseline. Calculated using the following formula: Meld = 10x ((0.957 x Ln(creatinine mg/dl)) + (0.378 x Ln(bilirubin mg/dl)) + (1.120 x Ln(INR)) + 0.643)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Vitamin D Repletion in Patients With Hepatocellular Carcinoma on the Orthotopic Liver Transplant List
Official Title  ICMJE The Effect of Vitamin D Repletion in Patients With Hepatocellular Carcinoma on the Orthotopic Liver Transplant List
Brief Summary The purpose of this study is to investigate the effect of two different doses of vitamin D3 (2000 IU vs. 4000 IU) on serum 25-hydroxyvitamin D (25OHD) levels in patients with hepatocellular carcinoma on the liver transplant list. The study will help determine the dose of vitamin D3 that is required for patients with liver cancer to reach a normal level of 25OHD in the blood.
Detailed Description

Potential participants will be identified from Mount Sinai Hospital's active liver transplant list. The hepatologists at Mount Sinai's Transplant Institute will ask each potential participant if she/he is interested in participating. If the patient expresses an interest in the study, one of the researchers will meet with the patient when the patient is at Mount Sinai for a regular appointment and will describe the study to the potential participant. If a patient continues to be interested in participating, she/he will be given a copy of the IRB-approved consent document to read. The consent document will be used as a guide for explaining the study in detail to the patient. If the patient's preferred language is Spanish, she/he will be given a consent document in Spanish and the study will be explained in Spanish.

Once the subject's 25(OH)D level is known, if the subject's 25(OH)D level is ≤ 15 ng/ml, the participant will be contacted by one of the investigators on the research team and instructed to begin taking 2 tablets per day (4000 IU total) of vitamin D. If the subject's 25(OH)D level is greater than 15 and ≤ 25, the participant will be contacted by one of the investigators on the research team and told to begin taking 1 tablet (2000 IU total) per day of vitamin D. If the participant's vitamin D level is < 25 ng/ml, they are considered Vitamin D insufficient/deficient. If the Serum Vitamin D is > 25 ng/ml they will be informed that they are not to take any vitamin D and they will be followed as controls for this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Vitamin D Deficiency
  • Hepatocellular Carcinoma
Intervention  ICMJE
  • Drug: Vitamin D3 4000 IU
    Participants with serum 25-hydroxyvitamin D levels of less than or equal to 15ng/ml will take 4000 IU of vitamin D3 daily by mouth for 6 months
    Other Name: Vitamin D 4000
  • Drug: Vitamin D3 2000 IU
    Participants with serum 25-hydroxyvitamin D levels of greater than 15 ng/ml and less than or equal to 25ng/ml will take 2000 IU of vitamin D3 daily by mouth for 6 months
    Other Name: Vitamin D 2000
Study Arms  ICMJE
  • Experimental: Vitamin D 4000
    Subjects taking 4000 IU of vitamin D
    Intervention: Drug: Vitamin D3 4000 IU
  • Experimental: Vitamin D 2000
    Subjects taking 2000IU of vitamin D
    Intervention: Drug: Vitamin D3 2000 IU
  • No Intervention: No Intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 9, 2012)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2013
Estimated Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult patients (18 years and older)
  • Diagnosis of hepatocellular carcinoma
  • On the list awaiting liver transplantation
  • Able to give informed consent
  • Expected to receive care following liver transplantation at the Mount Sinai School of Medicine
  • Any race/ethnicity/socioeconomic status

Exclusion Criteria:

  • Pediatric patient (less than 18 years of age)
  • Unable to give informed consent
  • Untreated primary hyperparathyroidism (ICD9 codes 252.01XX and 252.00XX)
  • Untreated hypercalcemia (serum calcium level > 11 mg/dl; ICD9 codes 275.42XX, 259.3XX, 252.00F)
  • Pregnancy (will be determined by asking the patient and reviewing the medical record)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01575717
Other Study ID Numbers  ICMJE GCO 11-1149
IF# 1333386
HS#: 11-02021
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andrea Branch, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Andrea Branch
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrea D Branch, PhD Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP