NCT01748448

Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 436 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cutaneous Malignant Melanoma

Interventions

Type	Name	Description
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
DRUG	Placebo: Oil

Timeline

• Start date: 2012-12-01
• Primary completion: 2022-07-01
• Completion: 2022-07-01
• First posted: 2012-12-12
• Last updated: 2025-02-17
• Results posted: 2025-02-17

Locations

4 sites across 2 countries: Belgium, Hungary