The Effect of Vitamin D Repletion in Patients With Hepatocellular Carcinoma on the Orthotopic Liver Transplant List
3 other identifiers
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 9, 2012
CompletedFirst Posted
Study publicly available on registry
April 11, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedOctober 24, 2012
October 1, 2012
1 year
April 9, 2012
October 22, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (6)
Change in serum levels of liver enzymes (ALT, AST and Alk phos)
at baseline, and at 3 and 6 months
Change in serum creatinine
at baseline, and at 3 and 6 months
Serum Calcium
at 3 months
Serum Calcium
at 6 months
Change in coagulation profile (PT/PTT and INR)
at baseline, and at 3 and 6 months
- +1 more secondary outcomes
Study Arms (3)
Vitamin D 4000
EXPERIMENTALSubjects taking 4000 IU of vitamin D
Vitamin D 2000
EXPERIMENTALSubjects taking 2000IU of vitamin D
No Intervention
NO INTERVENTIONInterventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Andrea Branchlead
Study Sites (1)
The Mount Sinai Hospital
New York, New York, 10029, United States
Related Publications (6)
Malham M, Jorgensen SP, Ott P, Agnholt J, Vilstrup H, Borre M, Dahlerup JF. Vitamin D deficiency in cirrhosis relates to liver dysfunction rather than aetiology. World J Gastroenterol. 2011 Feb 21;17(7):922-5. doi: 10.3748/wjg.v17.i7.922.
PMID: 21412501BACKGROUNDWibaux C, Legroux-Gerot I, Dharancy S, Boleslawski E, Declerck N, Canva V, Mathurin P, Pruvot FR, Cortet B. Assessing bone status in patients awaiting liver transplantation. Joint Bone Spine. 2011 Jul;78(4):387-91. doi: 10.1016/j.jbspin.2011.03.001. Epub 2011 May 11.
PMID: 21565541BACKGROUNDArteh J, Narra S, Nair S. Prevalence of vitamin D deficiency in chronic liver disease. Dig Dis Sci. 2010 Sep;55(9):2624-8. doi: 10.1007/s10620-009-1069-9. Epub 2009 Dec 4.
PMID: 19960254BACKGROUNDNinkovic M, Love SA, Tom B, Alexander GJ, Compston JE. High prevalence of osteoporosis in patients with chronic liver disease prior to liver transplantation. Calcif Tissue Int. 2001 Dec;69(6):321-6. doi: 10.1007/s00223-001-2028-4.
PMID: 11800228BACKGROUNDLoria I, Albanese C, Giusto M, Galtieri PA, Giannelli V, Lucidi C, Di Menna S, Pirazzi C, Corradini SG, Mennini G, Rossi M, Berloco P, Merli M. Bone disorders in patients with chronic liver disease awaiting liver transplantation. Transplant Proc. 2010 May;42(4):1191-3. doi: 10.1016/j.transproceed.2010.03.096.
PMID: 20534258BACKGROUNDBitetto D, Fabris C, Falleti E, Fornasiere E, Fumolo E, Fontanini E, Cussigh A, Occhino G, Baccarani U, Pirisi M, Toniutto P. Vitamin D and the risk of acute allograft rejection following human liver transplantation. Liver Int. 2010 Mar;30(3):417-44. doi: 10.1111/j.1478-3231.2009.02154.x. Epub 2009 Oct 22.
PMID: 19849776BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea D Branch, PhD
Icahn School of Medicine at Mount Sinai
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 9, 2012
First Posted
April 11, 2012
Study Start
January 1, 2012
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
October 24, 2012
Record last verified: 2012-10