Cutaneous Malignant MelanomaPhase 3ViDMeNCT01748448
Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome
A Phase 3 study testing Vitamin D in people with Cutaneous Malignant Melanoma, run by Universitaire Ziekenhuizen KU Leuven at 4 sites in 2 countries.
Trial summary
To assess whether vitamin D supplementation after surgery of a first cutaneous malignant melanoma protects against relapse of the disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cutaneous Malignant Melanoma
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 436 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Dec 2012to Jul 2022
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Belgium3 sites
Universitair Ziekenhuis Antwerpen, Dermatology
Edegem, 2650
UZLeuven Gasthuisberg
Leuven, 3000
Chef de Service du Service Universitaire de Dermatologie
Liège, 4000
Hungary1 site
Dep. of Dermatology, Medical and Health Science Center University of Debrecen
Debrecen, 4032
About this study
To assess whether vitamin D supplementation after surgery of a first cutaneous malignant melanoma protects against relapse of the disease.
Read the 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.
- Conditions
- Cutaneous Malignant Melanoma
- Being tested
- Vitamin D, Placebo: Oil
- Keywords
- Cutaneous malignant melanoma, Vitamin D, Cholecalciferol
- Medical subject headings
- Melanoma, Cutaneous Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Also called D-Cure, Cholecalciferol
- 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
Placebo: OilDrug
Also called Placebo
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Active comparator | 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 Receives: Drug: Vitamin D |
| Placebo: Oil | Placebo comparator | 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 Receives: Drug: Placebo: Oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse Free Survival
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.
Measured: study duration maximum 9 years and 7 months or until relapse
Secondary outcomes (4)
Melanoma Subtype, as Assessed Clinically and Histologically
Vitamin D levels at diagnosis will be correlated with melanoma subtype, as assessed clinically and histologically.
Measured: Time at diagnosis
Melanoma Site, as Clinically Recorded
Vitamin D levels at diagnosis will be correlated with melanoma site, as clinically recorded.
Measured: Time at diagnosis
25(OH)D3 Serum Levels
25(OH)D3 serum levels will be recorded at diagnosis and at 6 months intervals up to final study visit.
Measured: study duration maximum 3.5 years (Treatment period) or until relapse
Stage of Melanoma Patient
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.
Measured: Time at diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionJul 2022
- Study completionJul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cutaneous Malignant MelanomaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 436 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Sponsor
- Investigators
- Marjan Garmyn, MD, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748448
- Sponsor's protocol ID
- 2012LRDVDCM
- Other IDs
- 2012-002125-30
- Acronym
- ViDMe
- Status last verified
- Mar 2023
- First submitted
- 5 Dec 2012
- Last updated
- 17 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
De Smedt J, Van Kelst S, Boecxstaens V, Stas M, Bogaerts K, Vanderschueren D, Aura C, Vandenberghe K, Lambrechts D, Wolter P, Bechter O, Nikkels A, Strobbe T, Emri G, Marasigan V, Garmyn M. Vitamin D supplementation in cutaneous malignant melanoma outcome (ViDMe): a randomized controlled trial. BMC Cancer. 2017 Aug 23;17(1):562. doi: 10.1186/s12885-017-3538-4.
PubMed 28835228De Smedt J, Van Kelst S, Janssen L, Marasigan V, Boecxstaens V, Bogaerts K, Belmans A, Vanderschueren D, Vandenberghe K, Bechter O, Aura C, Lambrechts D, Strobbe T, Emri G, Nikkels A, Garmyn M. High-dose vitamin D supplementation does not improve outcome in a cutaneous melanoma population: results of a randomized double-blind placebo-controlled study (ViDMe trial). Br J Dermatol. 2024 Nov 18;191(6):886-896. doi: 10.1093/bjd/ljae257.
PubMed 38913652De Smedt J, Aura C, Van Kelst S, Janssen L, Marasigan V, Boecxstaens V, Stas M, Bogaerts K, Belmans A, Cleynen I, Vanderschueren D, Vandenberghe K, Bechter O, Nikkels A, Strobbe T, Emri G, Lambrechts D, Garmyn M. Clinical and genetic determinants of vitamin D receptor expression in cutaneous melanoma patients. Melanoma Res. 2024 Apr 1;34(2):125-133. doi: 10.1097/CMR.0000000000000929. Epub 2024 Feb 13.
PubMed 38348498De Smedt J, Van Kelst S, Janssen L, Marasigan V, Boecxstaens V, Stas M, Vanderschueren D, Guler I, Bogaerts K, Vandenberghe K, Bechter O, Billen J, Nikkels A, Strobbe T, Emri G, Lambrechts D, Garmyn M. Determinants of 25-hydroxyvitamin D Status in a Cutaneous Melanoma Population. Acta Derm Venereol. 2022 Apr 8;102:adv00692. doi: 10.2340/actadv.v102.262.
PubMed 35312026