Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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.
study duration maximum 3,5 years
Marjan Garmyn, MD, PhD
Universitaire Ziekenhuizen Leuven
Belgium: Federal Agency for Medicinal Products and Health Products