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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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
No
Andrea D Branch, PhD
Principal Investigator
Mount Sinai School of Medicine
United States: Food and Drug Administration
GCO 11-1149
NCT01575717
January 2012
January 2013
Name | Location |
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The Mount Sinai Hospital | New York, New York 10029 |