Publication: Vitamin D Supplementation and Disease-Free Survival in Stage II Melanoma: A Randomized Placebo Controlled Trial

Reference
Title	Vitamin D Supplementation and Disease-Free Survival in Stage II Melanoma: A Randomized Placebo Controlled Trial
Topic	Vitamin D
Author	Johansson, H, Spadola, G, Tosti, G, Mandalà, M, Minisini, AM, Queirolo, P, Aristarco, V, Baldini, F, Cocorocchio, E, Albertazzi, E, Zichichi, L, Cinieri, S, Jemos, C, Mazzarol, G, Gnagnarella, P, Macis, D, Tedeschi, I, Salè, EO, Stucci, LS, Bonanni, B, Testori, A, Pennacchioli, E, Ferrucci, PF, Gandini, S
Year	2021
Journal	nutritients
DOI	https://doi.org/10.3390/nu13061931

Author's Abstract The abstract and the information and conclusions contained therein were written by the authors of the publication.

Patients with newly resected stage II melanoma (n = 104) were randomized to receive adjuvant vitamin D3 (100,000 IU every 50 days) or placebo for 3 years to investigate vitamin D3 protective effects on developing a recurrent disease. Median age at diagnosis was 50 years, and 43% of the patients were female. Median serum 25-hydroxy vitamin D (25OHD) level at baseline was 18 ng/mL, interquartile range (IQ) was 13–24 ng/mL, and 80% of the patients had insufficient vitamin D levels. We observed pronounced increases in 25OHD levels after 4 months in the active arm (median 32.9 ng/mL; IQ range 25.9–38.4) against placebo (median 19.05 ng/mL; IQ range 13.0–25.9), constantly rising during treatment. Remarkably, patients with low Breslow score (<3 mm) had a double increase in 25OHD levels from baseline, whereas patients with Breslow score ≥3 mm had a significantly lower increase over time. After 12 months, subjects with low 25OHD levels and Breslow score ≥3 mm had shorter disease-free survival (p = 0.02) compared to those with Breslow score <3 mm and/or high levels of 25OHD. Adjusting for age and treatment arm, the hazard ratio for relapse was 4.81 (95% CI: 1.44–16.09, p = 0.011). Despite the evidence of a role of 25OHD in melanoma prognosis, larger trials with vitamin D supplementation involving subjects with melanoma are needed.

This publication is referenced in the following studies:

1. Johansson et al. (2021): Vitamin D Supplementation and Disease-Free Survival in Stage II Melanoma: A Randomized Placebo Controlled Trial