Know Cancer

or
forgot password

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


N/A
18 Years
N/A
Open (Enrolling)
Both
Vitamin D Deficiency, Hepatocellular Carcinoma

Thank you

Trial Information

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


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.


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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change in serum levels of 25-hydroxyvitamin D

Outcome Description:

Change in serum levels of 25-hydroxyvitamin D at 3 months and 6 months compared to baseline

Outcome Time Frame:

at baseline, and at 3 and 6 months

Safety Issue:

No

Principal Investigator

Andrea D Branch, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mount Sinai School of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

GCO 11-1149

NCT ID:

NCT01575717

Start Date:

January 2012

Completion Date:

January 2013

Related Keywords:

  • Vitamin D Deficiency
  • Hepatocellular Carcinoma
  • Vitamin D
  • hepatocellular carcinoma
  • liver neoplasms
  • liver transplantation
  • Carcinoma
  • Vitamin D Deficiency
  • Carcinoma, Hepatocellular

Name

Location

The Mount Sinai HospitalNew York, New York  10029