Recruiting

Vitamin D

Sponsor:

Andrea Branch

Code:

NCT01575717

Conditions

Vitamin D Deficiency

Hepatocellular Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vitamin D3 4000 IU

Vitamin D3 2000 IU

Study Details

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.

Conditions

Vitamin D Deficiency

Hepatocellular Carcinoma

Study ID

NCT01575717

Start date

Jan, 2012

Status verified date

Oct, 2012

Completion date

Jan, 2013

Anticipated

Primary completion date

Jan, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Vitamin D 4000

Subjects taking 4000 IU of vitamin D

experimental: Vitamin D 2000

Subjects taking 2000IU of vitamin D

no intervention: No Intervention

Interventions

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

Primary outcome measure

  • Change in serum levels of 25-hydroxyvitamin D [ Time Frame: at baseline, and at 3 and 6 months ]

Central Contacts and Locations

Central contacts

Andrea D Branch, PhD

212-659-8371andrea.branch@mssm.edu

Locations

The Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Principal Investigator:

Andrea D Branch, PhD

More Information

Sponsor

Andrea Branch

Last update posted

Oct 24, 2012

Last verified

Oct, 2012

Keywords

  • Vitamin D
  • hepatocellular carcinoma
  • liver neoplasms
  • liver transplantation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Andrea Branch on 2012-10-24.