Clinical trial · Interventional
The Effect of Vitamin D Repletion in Patients With Hepatocellular Carcinoma on the Orthotopic Liver Transplant List
NCT01575717CI-TRIAL-00008333unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Vitamin D Deficiency | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vitamin D3 2000 IU | Drug | — | UNRESOLVED |
| Vitamin D3 4000 IU | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Vitamin D 4000
- description
- Subjects taking 4000 IU of vitamin D
- interventionNames
- Drug: Vitamin D3 4000 IU
- type
- EXPERIMENTAL
- label
- Vitamin D 2000
- description
- Subjects taking 2000IU of vitamin D
- interventionNames
- Drug: Vitamin D3 2000 IU
- type
- NO_INTERVENTION
- label
- No Intervention
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (6)
- BACKGROUNDMalham 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 21412501
- BACKGROUNDWibaux 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 21565541
- BACKGROUNDArteh 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 19960254
- BACKGROUNDNinkovic 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 11800228
- BACKGROUNDLoria 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 20534258
- BACKGROUNDBitetto 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 19849776