Back to resultsVitamin D Supplementation in Cutaneous Malignant Melanoma Outcome (ViDMe)
Primary Purpose
Cutaneous Malignant Melanoma
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Vitamin D
arachides oleum raffinatum
Sponsored by
About this trial
This is an interventional treatment trial for Cutaneous Malignant Melanoma focused on measuring Cutaneous malignant melanoma, Vitamin D, Cholecalciferol
Eligibility 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.
Sites / Locations
- Universitair Ziekenhuis Antwerpen, Dermatology
- UZLeuven Gasthuisberg
- Chef de Service du Service Universitaire de Dermatologie
- Dep. of Dermatology, Medical and Health Science Center University of Debrecen
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Vitamin D
arachides oleum raffinatum
Arm Description
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
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
Outcomes
Primary Outcome Measures
Relapse free survival
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
Vitamin D levels at diagnosis will be correlated with melanoma subtype, as assessed clinically and histologically.
Melanoma site, as clinically recorded
Vitamin D levels at diagnosis will be correlated with melanoma site, as clinically recorded.
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. Genetic variability of Vitamin D pathway will be correlated with 25(OH)D3 serum levels
Stage of melanoma patient
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
Full Information
NCT ID
NCT01748448
First Posted
December 5, 2012
Last Updated
March 20, 2023
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT01748448
Brief Title
Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome
Acronym
ViDMe
Official Title
Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 2012 (Actual)
Primary Completion Date
July 2022 (Actual)
Study Completion Date
July 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
KU Leuven
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To assess whether vitamin D supplementation after surgery of a first cutaneous malignant melanoma protects against relapse of the disease.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Malignant Melanoma
Keywords
Cutaneous malignant melanoma, Vitamin D, Cholecalciferol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
436 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D
Arm Type
Active Comparator
Arm Description
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
Arm Title
arachides oleum raffinatum
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Other Intervention Name(s)
D-Cure, Cholecalciferol
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
arachides oleum raffinatum
Other Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Relapse free survival
Description
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.
Time Frame
study duration maximum 3,5 years
Secondary Outcome Measure Information:
Title
Melanoma subtype, as assessed clinically and histologically
Description
Vitamin D levels at diagnosis will be correlated with melanoma subtype, as assessed clinically and histologically.
Time Frame
study duration maximum 3,5 years
Title
Melanoma site, as clinically recorded
Description
Vitamin D levels at diagnosis will be correlated with melanoma site, as clinically recorded.
Time Frame
study duration maximum 3,5 years
Title
25(OH)D3 serum levels
Description
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
Time Frame
study duration maximum 3,5 years
Title
Stage of melanoma patient
Description
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
Time Frame
study duration maximum 3,5 years
Other Pre-specified Outcome Measures:
Title
Safety endpoints:Incidence and severity of adverse events
Description
Incidence and severity of adverse events will be recorded every 3 months up to final study visit.
Time Frame
study duration maximum 3,5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marjan Garmyn, MD, PhD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitair Ziekenhuis Antwerpen, Dermatology
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
UZLeuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Chef de Service du Service Universitaire de Dermatologie
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Dep. of Dermatology, Medical and Health Science Center University of Debrecen
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
12. IPD Sharing Statement
Citations:
PubMed Identifier
28835228
Citation
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.
Results Reference
derived
Learn more about this trial
Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome
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