MelaViD: A Trial on Vitamin D Supplementation for Resected Stage II Melanoma Patients (MelaViD)
|ClinicalTrials.gov Identifier: NCT01264874|
Recruitment Status : Terminated (poor accrual rate)
First Posted : December 22, 2010
Last Update Posted : January 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: Vitamin D3 ( Colecalciferol) Other: placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Phase III, Randomized, Double Blind Trial on Vitamin D Supplementation for Resected Stage II Melanoma Patients|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||July 2017|
|Actual Study Completion Date :||July 2017|
Experimental: Vitamin D3
Vitamin D3 administration
Drug: Vitamin D3 ( Colecalciferol)
100000 IU every 50 days for 3 years
Other Name: dibase
Placebo Comparator: placebo
For 3 years IU every 50 days
- Disease free survival and Overall Survival [ Time Frame: 3 years of treatment and 2 of follow up ]
Disease free survival (DFS) will be the primary end-point of efficacy in this Phase III trial. It will be measured from the date of randomization to the date of progression or death, whatever the cause.
Overall Survival will be also evaluated and it is defined as the time from the date of randomization to the date of death from any cause or to the date of last follow-up.
- Evaluation of Vitamin D receptors and 25(OH)D by Breslow thickness. [ Time Frame: baseline and after 1 year of treatment ]
Evaluation at baseline of Vitamin D receptors and 25(OH)D by Breslow thickness. Change in time of 25(OH)D serum level by VDR and other genes involved in vitamin D metabolisms.
Percentages of patients at desired levels of 25(OH)D (30 ng/ml) during 1 year. Toxicity.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01264874
|European Institute of Oncology|
|Milan, Italy, 20141|
|Principal Investigator:||Alessandro Testori, MD||European Institute of Oncology|