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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Mount Sinai School of Medicine
Sponsor:
Information provided by (Responsible Party):
Andrea Branch, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01575717
First received: April 9, 2012
Last updated: October 22, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Vitamin D Deficiency
Hepatocellular Carcinoma
Drug: Vitamin D3 4000 IU
Drug: Vitamin D3 2000 IU

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Vitamin D Repletion in Patients With Hepatocellular Carcinoma on the Orthotopic Liver Transplant List

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Change in serum levels of 25-hydroxyvitamin D [ Time Frame: at baseline, and at 3 and 6 months ] [ Designated as safety issue: No ]
    Change in serum levels of 25-hydroxyvitamin D at 3 months and 6 months compared to baseline


Secondary Outcome Measures:
  • Change in serum levels of liver enzymes (ALT, AST and Alk phos) [ Time Frame: at baseline, and at 3 and 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Change in serum creatinine at 3 months and at 6 months compared to baseline

  • Serum Calcium [ Time Frame: at 3 months ] [ Designated as safety issue: Yes ]
  • Serum Calcium [ Time Frame: at 6 months ] [ Designated as safety issue: Yes ]
  • Change in coagulation profile (PT/PTT and INR) [ Time Frame: at baseline, and at 3 and 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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)



Estimated Enrollment: 50
Study Start Date: January 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D 4000
Subjects taking 4000 IU of vitamin D
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
Experimental: Vitamin D 2000
Subjects taking 2000IU of vitamin D
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
No Intervention: No Intervention

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01575717

Contacts
Contact: Andrea D Branch, PhD 212-659-8371 andrea.branch@mssm.edu

Locations
United States, New York
The Mount Sinai Hospital Recruiting
New York, New York, United States, 10029
Principal Investigator: Andrea D Branch, PhD         
Sponsors and Collaborators
Andrea Branch
Investigators
Principal Investigator: Andrea D Branch, PhD Mount Sinai School of Medicine
  More Information

Publications:
Responsible Party: Andrea Branch, Principal Investigator, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01575717     History of Changes
Other Study ID Numbers: GCO 11-1149, IF# 1333386, HS#: 11-02021
Study First Received: April 9, 2012
Last Updated: October 22, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Mount Sinai School of Medicine:
Vitamin D
hepatocellular carcinoma
liver neoplasms
liver transplantation

Additional relevant MeSH terms:
Vitamin D
Ergocalciferols
Carcinoma
Vitamin D Deficiency
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Cholecalciferol
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 18, 2014