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

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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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Vitamin D Deficiency Hepatocellular Carcinoma	Drug: Vitamin D3 4000 IU Drug: Vitamin D3 2000 IU	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	50 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	The Effect of Vitamin D Repletion in Patients With Hepatocellular Carcinoma on the Orthotopic Liver Transplant List
Study Start Date :	January 2012
Estimated Primary Completion Date :	January 2013
Estimated Study Completion Date :	January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Transplantation Vitamin D

Drug Information available for: Vitamin D

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

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

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 ]
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)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575717

Contacts

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

Locations

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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

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Principal Investigator:	Andrea D Branch, PhD	Icahn School of Medicine at Mount Sinai

More Information

Publications:

Malham M, Jørgensen SP, Ott P, Agnholt J, Vilstrup H, Borre M, Dahlerup JF. Vitamin D deficiency in cirrhosis relates to liver dysfunction rather than aetiology. World J Gastroenterol. 2011 Feb 21;17(7):922-5. doi: 10.3748/wjg.v17.i7.922.

Wibaux C, Legroux-Gerot I, Dharancy S, Boleslawski E, Declerck N, Canva V, Mathurin P, Pruvot FR, Cortet B. Assessing bone status in patients awaiting liver transplantation. Joint Bone Spine. 2011 Jul;78(4):387-91. doi: 10.1016/j.jbspin.2011.03.001. Epub 2011 May 11.

Arteh J, Narra S, Nair S. Prevalence of vitamin D deficiency in chronic liver disease. Dig Dis Sci. 2010 Sep;55(9):2624-8. doi: 10.1007/s10620-009-1069-9. Epub 2009 Dec 4.

Ninkovic M, Love SA, Tom B, Alexander GJ, Compston JE. High prevalence of osteoporosis in patients with chronic liver disease prior to liver transplantation. Calcif Tissue Int. 2001 Dec;69(6):321-6.

Loria I, Albanese C, Giusto M, Galtieri PA, Giannelli V, Lucidi C, Di Menna S, Pirazzi C, Corradini SG, Mennini G, Rossi M, Berloco P, Merli M. Bone disorders in patients with chronic liver disease awaiting liver transplantation. Transplant Proc. 2010 May;42(4):1191-3. doi: 10.1016/j.transproceed.2010.03.096.

Bitetto D, Fabris C, Falleti E, Fornasiere E, Fumolo E, Fontanini E, Cussigh A, Occhino G, Baccarani U, Pirisi M, Toniutto P. Vitamin D and the risk of acute allograft rejection following human liver transplantation. Liver Int. 2010 Mar;30(3):417-44. doi: 10.1111/j.1478-3231.2009.02154.x. Epub 2009 Oct 22.

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Responsible Party:	Andrea Branch, Principal Investigator, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:	NCT01575717
Other Study ID Numbers:	GCO 11-1149 IF# 1333386 HS#: 11-02021
First Posted:	April 11, 2012 Key Record Dates
Last Update Posted:	October 24, 2012
Last Verified:	October 2012

Keywords provided by Andrea Branch, Icahn School of Medicine at Mount Sinai:


Vitamin D hepatocellular carcinoma liver neoplasms liver transplantation

Additional relevant MeSH terms:

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Carcinoma Carcinoma, Hepatocellular Vitamin D Deficiency Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases Avitaminosis	Deficiency Diseases Malnutrition Nutrition Disorders Vitamin D Ergocalciferols Cholecalciferol Vitamins Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents

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