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.
VitaminDWiki suspects that this trial will be successful AND that a similar amount of vitamin D will PREVENT malignant melanoma
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Download the PDF from VitaminDWikiBACKGROUND:
Previous studies have investigated the protective effect of vitamin D serum levels, at diagnosis and during the follow-up period after treatment, on melanoma outcome. In the present study we assess whether vitamin D supplementation, in the follow-up period after diagnosis and surgical resection of the primary tumor, 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 immunoreactivity in the primary tumor.METHODS/DESIGN:
This study is a multicenter randomized double blind placebo- controlled phase III trial. Patients between the age of 18 and 80 years diagnosed and treated surgically for a melanoma stage IB-III are eligible for randomization in a 1:1 ratio to active treatment or placebo. The study drug is taken each month and consists of either 100,000 International Unit cholecalciferol or arachidis oleum raffinatum used as a placebo. The primary endpoint is relapse free survival. The secondary endpoints are 25 hydroxyvitamin D3 serum levels at diagnosis and at 6 month intervals, melanoma subtype, melanoma site and stage of melanoma at diagnosis according to the 2009 American Joint Committee on Cancer melanoma staging and classification. At randomization a bloodsample is taken for DNA analysis. The study is approved by the local Ethics Committees.DISCUSSION:
If we can confirm our hypothesis that vitamin D supplementation after removal of the tumor has a protective effect on relapse of cutaneous malignant melanoma we may reduce the burden of CMM at several levels. Patients, diagnosed with melanoma may have a better clinical outcome and improved quality of life. There will be a decrease in health care costs related to treatment of metastatic disease and there will be a decrease in loss of professional years, which will markedly reduce the economic burden of the disease.TRIAL REGISTRATION: Clinical Trial.gov, NCT01748448 , 05/12/2012.
PMID: 28835228 DOI: 10.1186/s12885-017-3538-4
Recurrence of malignant melanoma may be reduced by 100,000 IU of vitamin D monthly – trial underway 2017Printer Friendly Follow this page for updates2990 visitors, last modified 13 Mar, 2021, This page is in the following categories (# of items in each category) - Breast Cancer and VDR