Vitamin D supplementation in cutaneous malignant melanoma outcome (ViDMe): a randomized controlled trial.

BACKGROUND: 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.

Calciphylaxis: a rare complication in alcoholic liver disease.

Calciphylaxis, or calcific uremic arteriolopathy (CUA) is a rare but well described entity in patients with endstage renal disease (ESRD) and/or hyperparathyroidism. CUA is characterized by systemic acute calcification of the small and intermediate dermal vasculature that can lead to epidermal ischemia, ulceration, and necrosis. Cutaneous lesions of calciphylaxis characteristically begin as tender, violaceous, livedoid discolorations. The mechanisms of disease remain poorly understood although abnormal bone and mineral metabolism and hyperparathyroidism can contribute to CUA. Therapeutic strategies are of unproven benefit and mortality remains high. Calciphylaxis has also been extremely rarely reported in patients without ESRD and/or hyperparathyroidism. We report an unusual case of calciphylaxis in a patient with alcoholic liver cirrhosis and normal renal function, without any alteration in the phosphocalcic and parathyroid hormone (PTH) metabolisms.