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

Andrea Branch

Status: Unknown

Conditions: Vitamin D Deficiency; Hepatocellular Carcinoma

Treatments: Drug: Vitamin D3 4000 IU; Drug: Vitamin D3 2000 IU

Study type: Interventional

Funder types: Other

Identifiers

NCT01575717

HS#: 11-02021

IF# 1333386

GCO 11-1149

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

Vitamin D 4000

Experimental group

Description:

Subjects taking 4000 IU of vitamin D

Treatment:

Drug: Vitamin D3 4000 IU

Vitamin D 2000

Experimental group

Description:

Subjects taking 2000IU of vitamin D

Treatment:

Drug: Vitamin D3 2000 IU

No Intervention

No Intervention group