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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01575717
• Other study ID #: GCO 11-1149
• Secondary ID: IF# 1333386HS#:
• Status: Unknown status
• Phase: N/A
• First received: April 9, 2012
• Last updated: October 22, 2012
• Start date: January 2012
• Est. completion date: January 2013

Study information

• Verified date: October 2012
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Andrea D Branch, PhD
• Phone: 212-659-8371
• Email: andrea.branch[@]mssm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 50
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Vitamin D Deficiency

Intervention

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
• 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

Locations

Country	Name	City	State
United States	The Mount Sinai Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Andrea Branch

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum levels of 25-hydroxyvitamin D	Change in serum levels of 25-hydroxyvitamin D at 3 months and 6 months compared to baseline	at baseline, and at 3 and 6 months
Secondary	Change in serum levels of liver enzymes (ALT, AST and Alk phos)	Change in serum levels of liver enzymes (ALT, AST and Alk phos) at 3 months and at 6 months compared to baseline	at baseline, and at 3 and 6 months
Secondary	Change in serum creatinine	Change in serum creatinine at 3 months and at 6 months compared to baseline	at baseline, and at 3 and 6 months
Secondary	Serum Calcium		at 3 months
Secondary	Serum Calcium		at 6 months
Secondary	Change in coagulation profile (PT/PTT and INR)	Change in coagulation profile (PT/PTT and INR) at 3 months and at 6 months compared to baseline	at baseline, and at 3 and 6 months
Secondary	Change in Model for End stage Liver Disease score (MELD)	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)	at baseline, and at 3 and 6 months