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Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome (ViDMe)

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ClinicalTrials.gov Identifier: NCT01748448
Recruitment Status : Recruiting
First Posted : December 12, 2012
Last Update Posted : May 27, 2019
Sponsor:
Collaborator:
KU Leuven
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Tracking Information
First Submitted Date  ICMJE December 5, 2012
First Posted Date  ICMJE December 12, 2012
Last Update Posted Date May 27, 2019
Study Start Date  ICMJE December 2012
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01748448 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2012)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 11, 2012)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome
Official Title  ICMJE Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cutaneous Malignant Melanoma
Intervention  ICMJE
  • 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
  • Drug: arachides oleum raffinatum
    Other Name: Placebo
Study Arms  ICMJE
  • 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
    Intervention: Drug: Vitamin D
  • 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
    Intervention: Drug: arachides oleum raffinatum
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 11, 2012)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marjan Garmyn, MD, PhD +32 16337950 ext 37950 marjan.garmyn@uzleuven.be
Contact: Julie Desmedt, MD +32 16337864 ext 37864 Julie.Desmedt@uzleuven.be
Listed Location Countries  ICMJE Belgium,   Hungary
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01748448
Other Study ID Numbers  ICMJE 2012LRDVDCM
2012-002125-30 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Universitaire Ziekenhuizen Leuven
Study Sponsor  ICMJE Universitaire Ziekenhuizen Leuven
Collaborators  ICMJE KU Leuven
Investigators  ICMJE
Principal Investigator: Marjan Garmyn, MD, PhD Universitaire Ziekenhuizen Leuven
PRS Account Universitaire Ziekenhuizen Leuven
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP