The Effect of Vitamin D Repletion in Patients With Hepatocellular Carcinoma on the Orthotopic Liver Transplant List
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| ClinicalTrials.gov Identifier: NCT01575717 |
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Recruitment Status : Unknown
Verified October 2012 by Andrea Branch, Icahn School of Medicine at Mount Sinai.
Recruitment status was: Recruiting
First Posted : April 11, 2012
Last Update Posted : October 24, 2012
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Vitamin D Deficiency Hepatocellular Carcinoma | Drug: Vitamin D3 4000 IU Drug: Vitamin D3 2000 IU | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | The Effect of Vitamin D Repletion in Patients With Hepatocellular Carcinoma on the Orthotopic Liver Transplant List |
| Study Start Date : | January 2012 |
| Estimated Primary Completion Date : | January 2013 |
| Estimated Study Completion Date : | January 2013 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Vitamin D 4000
Subjects taking 4000 IU of vitamin D
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Drug: Vitamin D3 4000 IU
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
Other Name: Vitamin D 4000 |
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Experimental: Vitamin D 2000
Subjects taking 2000IU of vitamin D
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Drug: Vitamin D3 2000 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
Other Name: Vitamin D 2000 |
| No Intervention: No Intervention |
- Change in serum levels of 25-hydroxyvitamin D [ Time Frame: 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
- Change in serum levels of liver enzymes (ALT, AST and Alk phos) [ Time Frame: 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 [ Time Frame: at baseline, and at 3 and 6 months ]Change in serum creatinine at 3 months and at 6 months compared to baseline
- Serum Calcium [ Time Frame: at 3 months ]
- Serum Calcium [ Time Frame: at 6 months ]
- Change in coagulation profile (PT/PTT and INR) [ Time Frame: 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) [ Time Frame: 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)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575717
| Contact: Andrea D Branch, PhD | 212-659-8371 | andrea.branch@mssm.edu |
| United States, New York | |
| The Mount Sinai Hospital | Recruiting |
| New York, New York, United States, 10029 | |
| Principal Investigator: Andrea D Branch, PhD | |
| Principal Investigator: | Andrea D Branch, PhD | Icahn School of Medicine at Mount Sinai |
| Responsible Party: | Andrea Branch, Principal Investigator, Icahn School of Medicine at Mount Sinai |
| ClinicalTrials.gov Identifier: | NCT01575717 |
| Other Study ID Numbers: |
GCO 11-1149 IF# 1333386 HS#: 11-02021 |
| First Posted: | April 11, 2012 Key Record Dates |
| Last Update Posted: | October 24, 2012 |
| Last Verified: | October 2012 |
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Vitamin D hepatocellular carcinoma liver neoplasms liver transplantation |
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Carcinoma Carcinoma, Hepatocellular Vitamin D Deficiency Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases Avitaminosis |
Deficiency Diseases Malnutrition Nutrition Disorders Vitamin D Ergocalciferols Cholecalciferol Vitamins Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents |