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
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Condition or disease | Intervention/treatment | Phase |
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Cutaneous Malignant Melanoma | Drug: Vitamin D Drug: arachides oleum raffinatum | Phase 3 |
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 |
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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
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Drug: Vitamin D
Other Names:
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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
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Drug: arachides oleum raffinatum
Other Name: Placebo |
- 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.
- 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.
- 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.
- 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
- 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
- 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:
- 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.

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
Belgium | |
Universitair Ziekenhuis Antwerpen, Dermatology | |
Edegem, Belgium, 2650 | |
UZLeuven Gasthuisberg | |
Leuven, Belgium, 3000 | |
Chef de Service du Service Universitaire de Dermatologie | |
Liège, Belgium, 4000 | |
Hungary | |
Dep. of Dermatology, Medical and Health Science Center University of Debrecen | |
Debrecen, Hungary, 4032 |
Principal Investigator: | Marjan Garmyn, MD, PhD | Universitaire Ziekenhuizen Leuven |
Responsible Party: | Universitaire Ziekenhuizen 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 |
Cutaneous malignant melanoma Vitamin D Cholecalciferol |
Melanoma Skin Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |
Neoplasms by Site Skin Diseases Vitamin D Cholecalciferol Vitamins Micronutrients Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents |