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Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome (ViDMe)
This study is ongoing, but not recruiting participants.
Sponsor:
Universitaire Ziekenhuizen Leuven
Collaborator:
Katholieke Universiteit Leuven
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01748448
First received: December 5, 2012
Last updated: May 15, 2017
Last verified: October 2016
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Purpose
To assess whether vitamin D supplementation after surgery of a first cutaneous malignant melanoma protects against relapse of the disease.
| Condition | Intervention | Phase |
|---|---|---|
| Cutaneous Malignant Melanoma | Drug: Vitamin D Drug: arachides oleum raffinatum | Phase 3 |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Drug Information available for:
Vitamin D
Genetic and Rare Diseases Information Center resources:
Melanoma, Familial
Carcinoid Tumor
Neuroepithelioma
U.S. FDA Resources
Further study details as provided by Universitaire Ziekenhuizen Leuven:
Primary Outcome Measures:
- 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:
- 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
Other Outcome Measures:
- 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.
| Estimated Enrollment: | 500 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | September 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
Other Names:
|
|
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 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748448
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748448
Locations
| Belgium | |
| Universitair Ziekenhuis Antwerpen, Dermatology | |
| Edegem, Belgium, 2650 | |
| UZ Sint Rafael ( UZLeuven) | |
| 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 | |
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Katholieke Universiteit Leuven
Investigators
| Principal Investigator: | Marjan Garmyn, MD, PhD | Universitaire Ziekenhuizen Leuven |
More Information
| Responsible Party: | Universitaire Ziekenhuizen Leuven |
| ClinicalTrials.gov Identifier: | NCT01748448 History of Changes |
| Other Study ID Numbers: |
2012LRDVDCM 2012-002125-30 ( EudraCT Number ) |
| Study First Received: | December 5, 2012 |
| Last Updated: | May 15, 2017 |
Keywords provided by Universitaire Ziekenhuizen Leuven:
|
Cutaneous malignant melanoma Vitamin D Cholecalciferol |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |
Vitamins Vitamin D Ergocalciferols Cholecalciferol Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on August 18, 2017