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Vitamin D DeficiencyNCT01575717

The Effect of Vitamin D Repletion in Patients With Hepatocellular Carcinoma on the Orthotopic Liver Transplant List

A study testing Vitamin D3 4000 IU and Vitamin D3 2000 IU in people with Vitamin D Deficiency and Hepatocellular Carcinoma, run by Andrea Branch at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Vitamin D3 4000 IU and Vitamin D3 2000 IU
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
Jan 2012to Jan 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Andrea D Branch, PhD contact

212-659-8371

andrea.branch@mssm.edu

United States1 site, 1 recruiting

  • The Mount Sinai Hospital

    New York, New York, 10029

    Andrea D Branch, PhD

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

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.

Being tested
Vitamin D3 4000 IU, Vitamin D3 2000 IU
Keywords
Vitamin D, hepatocellular carcinoma, liver neoplasms, liver transplantation
Medical subject headings
Vitamin D Deficiency, Carcinoma, Hepatocellular, Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin D3 4000 IUDrug

    Also called Vitamin D 4000

    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 IUDrug

    Also called Vitamin D 2000

    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

Study groups in NCT01575717
Study groupRoleWhat they receive
Vitamin D 4000ExperimentalSubjects taking 4000 IU of vitamin D
Receives: Drug: Vitamin D3 4000 IU
Vitamin D 2000ExperimentalSubjects taking 2000IU of vitamin D
Receives: Drug: Vitamin D3 2000 IU
No InterventionNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: at baseline, and at 3 and 6 months

Secondary outcomes (6)

  1. Change in serum levels of liver enzymes (ALT, AST and Alk phos)

    Change in serum levels of liver enzymes (ALT, AST and Alk phos) at 3 months and at 6 months compared to baseline

    Measured: at baseline, and at 3 and 6 months

  2. Change in serum creatinine

    Change in serum creatinine at 3 months and at 6 months compared to baseline

    Measured: at baseline, and at 3 and 6 months

  3. Serum Calcium

    Measured: at 3 months

  4. Serum Calcium

    Measured: at 6 months

  5. Change in coagulation profile (PT/PTT and INR)

    Change in coagulation profile (PT/PTT and INR) at 3 months and at 6 months compared to baseline

    Measured: at baseline, and at 3 and 6 months

  6. Change in Model for End stage Liver Disease score (MELD)

    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)

    Measured: at baseline, and at 3 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionJan 2013 (estimated)
  4. Study completionJan 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01575717
Sponsor's protocol ID
GCO 11-1149
Other IDs
IF# 1333386, HS#: 11-02021
Status last verified
Oct 2012
First submitted
9 Apr 2012
Last updated
24 Oct 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 21412501

  • 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.

    PubMed 21565541

  • 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.

    PubMed 19960254

  • 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.

    PubMed 11800228

  • 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.

    PubMed 20534258

  • 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.

    PubMed 19849776

Questions about this trial

What is this clinical trial studying?

A study testing Vitamin D3 4000 IU and Vitamin D3 2000 IU in people with Vitamin D Deficiency and Hepatocellular Carcinoma, run by Andrea Branch at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Andrea D Branch, PhD (212-659-8371, andrea.branch@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in serum levels of 25-hydroxyvitamin D (time frame: at baseline, and at 3 and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01575717, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2012.

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