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Trial record 1 of 1 for:    Melanoma | Vitamin D | Belgium
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Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome (ViDMe)

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ClinicalTrials.gov Identifier: NCT01748448
Recruitment Status : Active, not recruiting
First Posted : December 12, 2012
Last Update Posted : May 19, 2022
KU Leuven
Information provided by (Responsible Party):
Universitaire Ziekenhuizen KU Leuven

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

Condition or disease Intervention/treatment Phase
Cutaneous Malignant Melanoma Drug: Vitamin D Drug: arachides oleum raffinatum Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome
Study Start Date : December 2012
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : December 2023

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:
  • D-Cure
  • Cholecalciferol

Placebo Comparator: arachides oleum raffinatum
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: arachides oleum raffinatum
Other Name: Placebo

Primary Outcome Measures :
  1. Relapse free survival [ Time Frame: study duration maximum 3,5 years ]
    Disease free survival will be the primary endpoint of this phase III trial. Patients are enrolled during a recruitment phase of three years maximum. Study duration for one patient is maximum 3,5 years or until relapse occurs.

Secondary Outcome Measures :
  1. Melanoma subtype, as assessed clinically and histologically [ Time Frame: study duration maximum 3,5 years ]
    Vitamin D levels at diagnosis will be correlated with melanoma subtype, as assessed clinically and histologically.

  2. Melanoma site, as clinically recorded [ Time Frame: study duration maximum 3,5 years ]
    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 ]
    25(OH)D3 serum levels will be recorded at diagnosis and at 6 months intervals up to final study visit. Genetic variability of Vitamin D pathway will be correlated with 25(OH)D3 serum levels

  4. Stage of melanoma patient [ Time Frame: study duration maximum 3,5 years ]
    Vitamin D levels at diagnosis and genetic variability of the vitamin D pathway will be correlated with stage of melanoma patient at diagnosis according to the 2009 American Joint Committee of Cancer (AJCC) Melanoma staging and classification

Other Outcome Measures:
  1. Safety endpoints:Incidence and severity of adverse events [ Time Frame: study duration maximum 3,5 years ]
    Incidence and severity of adverse events will be recorded every 3 months up to final study visit.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01748448

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Universitair Ziekenhuis Antwerpen, Dermatology
Edegem, Belgium, 2650
UZLeuven Gasthuisberg
Leuven, Belgium, 3000
Chef de Service du Service Universitaire de Dermatologie
Liège, Belgium, 4000
Dep. of Dermatology, Medical and Health Science Center University of Debrecen
Debrecen, Hungary, 4032
Sponsors and Collaborators
Universitaire Ziekenhuizen KU Leuven
KU Leuven
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Principal Investigator: Marjan Garmyn, MD, PhD Universitaire Ziekenhuizen KU Leuven
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Universitaire Ziekenhuizen KU Leuven
ClinicalTrials.gov Identifier: NCT01748448    
Other Study ID Numbers: 2012LRDVDCM
2012-002125-30 ( EudraCT Number )
First Posted: December 12, 2012    Key Record Dates
Last Update Posted: May 19, 2022
Last Verified: May 2022
Keywords provided by Universitaire Ziekenhuizen KU Leuven:
Cutaneous malignant melanoma
Vitamin D
Additional relevant MeSH terms:
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Nevi and Melanomas
Vitamin D
Skin Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms by Site
Skin Diseases
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents