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Completed

NCT Number: NCT01748448

Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome

To assess whether vitamin D supplementation after surgery of a first cutaneous malignant melanoma protects against relapse of the disease.

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Key information

Conditions

Cutaneous Malignant Melanoma Melanoma Melanoma, Cutaneous Malignant Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Universitair Ziekenhuis Antwerpen, Dermatology, Edegem, Belgium

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnant/lactating women or planning on becoming pregnant during the study
  • Known hypersensitivity to vitamin D or its components.
  • Pre-existing renal stone disease, chronic renal disease with glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 or renal dialysis.
  • Liver failure or chronic liver disease with liver enzymes > 2 fold upper limit of normal (ULN).
  • History of parathyroid disease or granulomatous disease (TBC and sarcoidosis)
  • History of malabsorption syndrome or any medical condition that might interfere with vitamin D absorption.
  • History of small intestine resection.
  • 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.
  • Chronic alcohol abuse.
  • Medical or logistic problems likely to preclude completion of the study.
  • 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)
  • Intake of vitamin D supplements within 6 months prior to entry of the study.

Treatment and study plan

Vitamin D

Drug
  • 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: D-Cure, Cholecalciferol

Placebo: Oil

Drug

Other names: Placebo

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Melanoma Site, as Clinically Recorded

    Time frame: Time at diagnosis

    Vitamin D levels at diagnosis will be correlated with melanoma site, as clinically recorded.

  3. 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.

  4. 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.

Other outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • KU Leuven

Registry information

Acronym: ViDMe

Important dates

Study start
2012
Primary completion
2022
Study completion
2022
First posted
Dec 12, 2012
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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