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

  • 2021-06-04
  • Nutrients 13(6)
    • Harriet Johansson
    • Giuseppe Spadola
    • Giulio Tosti
    • Mario Mandalà
    • Alessandro M Minisini
    • Paola Queirolo
    • Valentina Aristarco
    • Federica Baldini
    • Emilia Cocorocchio
    • Elena Albertazzi
    • Leonardo Zichichi
    • Saverio Cinieri
    • Costantino Jemos
    • Giovanni Mazzarol
    • Patrizia Gnagnarella
    • Debora Macis
    • Ines Tedeschi
    • Emanuela Omodeo Salè
    • Luigia Stefania Stucci
    • Bernardo Bonanni
    • Alessandro Testori
    • Elisabetta Pennacchioli
    • Pier Francesco Ferrucci
    • Sara Gandini
    • On Behalf Of The Italian Melanoma Intergroup Imi

Study Design

Type
Randomized Controlled Trial (RCT)
Population
104 patients with newly resected stage II melanoma
Methods
randomized to receive adjuvant vitamin D3 (100,000 IU every 50 days) or placebo for 3 years
Blinding
Double-blind
Duration
3 years
Funding
Unclear
  • Rigorous Journal
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.

Research Insights

  • Vitamin D→Reduced Disease Recurrence

    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).

    Effect
    Beneficial
    Effect size
    Large
    Dose
    100,000 IU every 50 days
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