The Effect of Vitamin D Repletion in Patients With Hepatocellular Carcinoma on the Orthotopic Liver Transplant List
NCT ID: NCT01575717
Last Updated: 2012-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
50 participants
INTERVENTIONAL
2012-01-31
2013-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Vitamin D 4000
Subjects taking 4000 IU of vitamin D
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
Vitamin D 2000
Subjects taking 2000IU of vitamin D
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
No Intervention
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Andrea Branch
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Andrea Branch
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Andrea D Branch, PhD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Mount Sinai Hospital
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Wibaux 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.
Arteh 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.
Ninkovic 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.
Loria 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.
Bitetto 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IF# 1333386
Identifier Type: -
Identifier Source: secondary_id
HS#: 11-02021
Identifier Type: -
Identifier Source: secondary_id
GCO 11-1149
Identifier Type: -
Identifier Source: org_study_id