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

Not Applicable

• Conditions: Vitamin D Deficiency; Hepatocellular Carcinoma
• Interventions: Drug: Vitamin D3 4000 IU; Drug: Vitamin D3 2000 IU

• Registration Number: NCT01575717
• Lead Sponsor: Andrea Branch

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 Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-04-09
• Study First Submitted QC: 2012-04-09
• Study First Posted: 2012-04-11
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-22
• Last Update Posted: 2012-10-24
• Primary Completion: 2013-01
• Study Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D 4000	Vitamin D3 4000 IU	Subjects taking 4000 IU of vitamin D
Vitamin D 2000	Vitamin D3 2000 IU	Subjects taking 2000IU of vitamin D

Primary Outcome Measures

Name	Time	Method
Change in serum levels of 25-hydroxyvitamin D	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

Name	Time	Method
Change in serum levels of liver enzymes (ALT, AST and Alk phos)	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	at baseline, and at 3 and 6 months	Change in serum creatinine at 3 months and at 6 months compared to baseline
Serum Calcium	at 6 months
Change in coagulation profile (PT/PTT and INR)	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)	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)

Trial Locations

Locations (1)

The Mount Sinai Hospital; 🇺🇸 New York, New York, United States