Melanoma not treated by small doses of vitamin D (100,000 IU every 50 days) – RCT

Created June 2021

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

Nutrients 2021, 13(6), 1931; https://doi.org/10.3390/nu13061931

by Harriet Johansson 1,*OrcID,Giuseppe Spadola 2OrcID,Giulio Tosti 3OrcID,Mario Mandalà 4,†,Alessandro M. Minisini 5,†,Paola Queirolo 6,†,Valentina Aristarco 1OrcID,Federica Baldini 3,Emilia Cocorocchio 7,†,Elena Albertazzi 8,Leonardo Zichichi 9,†,Saverio Cinieri 10,Costantino Jemos 11,Giovanni Mazzarol 12,Patrizia Gnagnarella 13OrcID,Debora Macis 1OrcID,Ines Tedeschi 3,Emanuela Omodeo Salè 11,Luigia Stefania Stucci 14,†OrcID,Bernardo Bonanni 1OrcID,Alessandro Testori 15,16,†,Elisabetta Pennacchioli 3,Pier Francesco Ferrucci 17,†OrcID,Sara Gandini 18,†OrcID andon behalf of the Italian Melanoma Intergroup (IMI) † Member of the Italian Melanoma Intergroup (IMI), 16121 Genoa, Italy

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.

The Vitamin D levels in this RCT got to about 35 ng. Many cancers do not benefit from <50 ng

Many successful vitamin D trials use 50,000 IU every week or every two weeks

The RCT on this page used the equivalent to 50,000 IU once every 3 weeks

Receptor was not considered by the study on this page

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