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Vitamin

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

N/A
Waitlist Available
Led By Andrea D Branch, PhD
Research Sponsored by Andrea Branch
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, and at 3 and 6 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group

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.

Eligible Conditions
  • Vitamin D Deficiency
  • Liver Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, and at 3 and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, and at 3 and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in serum levels of 25-hydroxyvitamin D
Secondary study objectives
Change in Model for End stage Liver Disease score (MELD)
Change in coagulation profile (PT/PTT and INR)
Change in serum creatinine
+1 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Vitamin D 4000Experimental Treatment1 Intervention
Subjects taking 4000 IU of vitamin D
Group II: Vitamin D 2000Experimental Treatment1 Intervention
Subjects taking 2000IU of vitamin D
Group III: No InterventionActive Control1 Intervention

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Who is running the clinical trial?

Andrea BranchLead Sponsor
1 Previous Clinical Trials
62 Total Patients Enrolled
Andrea D Branch, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
3 Previous Clinical Trials
222 Total Patients Enrolled
~4 spots leftby Jan 2026
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