Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome (ViDMe)

January 30, 2025 updated by: Universitaire Ziekenhuizen KU Leuven
To assess whether vitamin D supplementation after surgery of a first cutaneous malignant melanoma protects against relapse of the disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To assess whether vitamin D supplementation, in the follow up period after diagnosis and surgery of a first cutaneous malignant melanoma, has a protective effect on relapse of cutaneous malignant melanoma and whether this protective effect correlates with vitamin D levels in serum and vitamin D receptor (VDR) immunoreactivity in the primary tumor.

Study Type

Interventional

Enrollment (Actual)

436

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Edegem, Belgium, 2650
        • Universitair Ziekenhuis Antwerpen, Dermatology
      • Leuven, Belgium, 3000
        • UZLeuven Gasthuisberg
      • Liège, Belgium, 4000
        • Chef de Service du Service Universitaire de Dermatologie
  • Hungary
      • Debrecen, Hungary, 4032
        • Dep. of Dermatology, Medical and Health Science Center University of Debrecen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Older than 18 years and younger than 80 years of age.
  2. Histologically proven malignant melanoma, stage one B (IB) to three (III) Not participating in other clinical trial.
  3. The only treatment for melanoma is surgical treatment.
  4. Complete resection of melanoma.
  5. Single primary invasive cutaneous melanoma
  6. Signed ethical committee approved informed consent
  7. Serum phosphate, serum calcium at the entry of the study within normal limits of laboratory reference

Exclusion criteria

  1. Pregnant/lactating women or planning on becoming pregnant during the study
  2. Known hypersensitivity to vitamin D or its components.
  3. Pre-existing renal stone disease, chronic renal disease with glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 or renal dialysis.
  4. Liver failure or chronic liver disease with liver enzymes > 2 fold upper limit of normal (ULN).
  5. History of parathyroid disease or granulomatous disease (TBC and sarcoidosis)
  6. History of malabsorption syndrome or any medical condition that might interfere with vitamin D absorption.
  7. History of small intestine resection.
  8. History of other malignancy within the last 5 years except for carcinoma in situ of the cervix or basal cell carcinoma or squamous cell carcinoma of the skin or in situ malignant melanoma.
  9. Chronic alcohol abuse.
  10. Medical or logistic problems likely to preclude completion of the study.
  11. Taking medication that predisposes to hypercalcemia (digoxin, lithium, thiazide diuretics) or taking medication that would affect metabolism of vitamin D (anticonvulsants, corticosteroids, H2-receptor antagonists)
  12. Intake of vitamin D supplements within 6 months prior to entry of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vitamin D
Every month 100 000 units of Vitamin D in syringe oral dispenser is taken . Study duration is maximum 3,5 years or until relapse occurs
Drug: Vitamin D
  • prospective interventional randomized double blind placebo controlled trail
  • clinical setting (tertiary university hospital)
  • investigator driven, no pharmaceutical sponsor
  • cutaneous malignant melanoma patients
  • add- on study (placebo or vitamin D) on top of optimal standard care
  • 1:1 inclusion ratio (placebo:Vitamin D)
  • randomisation after informed consent and screening
Other Names:
  • Cholecalciferol
  • D-Cure
Placebo Comparator: Placebo: Oil
Every month 100 000 units of vitamin D in syringe Oral dispenser is taken. Study duration is maximum of 3.5 years or until relapse occurs
Drug: Placebo: Oil
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relapse Free Survival
Time Frame: study duration maximum 9 years and 7 months or until relapse
Disease free survival will be the primary endpoint of this phase III trial. Study duration for one patient is maximum 9 years and 7 months. Patients are supplemented with studymedication (Vitamin D or placebo) for maximum 3.5 years. This is the treatment period. After the treatment period (in which the patients take study medication, placebo or Vitamin D), there is the follow-up period, no more study medication is taken, the study is still double blind, and the patients are followed at the clinical department for relapse and/or death.
study duration maximum 9 years and 7 months or until relapse

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Melanoma Subtype, as Assessed Clinically and Histologically
Time Frame: Time at diagnosis
Vitamin D levels at diagnosis will be correlated with melanoma subtype, as assessed clinically and histologically.
Time at diagnosis
Melanoma Site, as Clinically Recorded
Time Frame: Time at diagnosis
Vitamin D levels at diagnosis will be correlated with melanoma site, as clinically recorded.
Time at diagnosis
25(OH)D3 Serum Levels
Time Frame: study duration maximum 3.5 years (Treatment period) or until relapse
25(OH)D3 serum levels will be recorded at diagnosis and at 6 months intervals up to final study visit.
study duration maximum 3.5 years (Treatment period) or until relapse
Stage of Melanoma Patient
Time Frame: Time at diagnosis

Stage of melanoma patient at diagnosis according to the 8th American Joint Committee of Cancer (AJCC) Melanoma staging and classification.

The eighth edition of the AJCC staging system is currently the most widely accepted and standardized approach to melanoma staging and classification at initial diagnosis. Melanoma staging is based on the American Joint Committee on Cancer (AJCC) staging system that uses three key pieces of information for assigning Tumor-Node-Metastasis (TNM) classifications. AJCC staging ifacilitates accurate risk stratification and is essential to guide patient treatment.

The higher the stage, the more severe the melanoma.
Time at diagnosis

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Endpoints:Incidence and Severity of Adverse Events
Time Frame: study duration maximum 3.5 years (Treatment period) or until relapse
Incidence and severity of adverse events will be recorded every 3 months up to final study visit (from the treatment period).
study duration maximum 3.5 years (Treatment period) or until relapse

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

KU Leuven

Investigators

  • Principal Investigator: Marjan Garmyn, MD, PhD, Universitaire Ziekenhuizen KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2012

Primary Completion (Actual)

July 1, 2022

Study Completion (Actual)

July 1, 2022

Study Registration Dates

First Submitted

December 5, 2012

First Submitted That Met QC Criteria

December 11, 2012

First Posted (Estimated)

December 12, 2012

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 30, 2025

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012LRDVDCM
  • 2012-002125-30 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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