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

• 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
  
  

• 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)

  
  

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.