Neoplasms

All Conditions

Digestive System Diseases

Nutritional and Metabolic Diseases

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Vitamin D Deficiency

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Avitaminosis

Deficiency Diseases

Malnutrition

Nutrition Disorders

Bone Density Conservation Agents

Micronutrients

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Hematinics

Vitamins

Vitamin D

Cholecalciferol

Liver Extracts

Hydroxycholecalciferols

Calcifediol

Ergocalciferols

Trace Elements

Hormones

Calcium

Calcium, Dietary

Vitamin D3

Calciferol

Ergocalciferol

Vitamin D2

Participants with serum 25-hydroxyvitamin D levels of less than or equal to 15ng/ml will take 4000 IU of vitamin D3 daily by mouth for 6 months

Vitamin D3 4000 IU

Participants with serum 25-hydroxyvitamin D levels of greater than 15 ng/ml and less than or equal to 25ng/ml will take 2000 IU of vitamin D3 daily by mouth for 6 months

Vitamin D3 2000 IU

Andrea D Branch, PhD

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.

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.

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 at 3 months and 6 months compared to baseline

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 3 months and at 6 months compared to baseline

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 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)

Andrea Branch

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The Effect of Vitamin D Repletion in Patients With Hepatocellular Carcinoma on the Orthotopic Liver Transplant List	NCT01575717	Vitamin D Defic... Hepatocellular ...	Vitamin D3 4000... Vitamin D3 2000...	18 Years -	Icahn School of Medicine at Mount Sinai
The Effect of Vitamin D Repletion in Patients With Hepatocellular Carcinoma on the Orthotopic Liver Transplant List	NCT01575717	Vitamin D Defic... Hepatocellular ...	Vitamin D3 4000... Vitamin D3 2000...	18 Years -	Icahn School of Medicine at Mount Sinai

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