High-dose vitamin D supplementation does not improve outcome in a cutaneous melanoma population: results of a randomized double-blind placebo-controlled study (ViDMe trial).

What Was Tested

Researchers studied Vitamin D, K2, Magnesium and Zinc in this randomized controlled trial publication.

Observational studies in cutaneous melanoma (CM) have indicated an inverse relationship between levels of 25-hydroxyvitamin D and Breslow thickness, in addition to a protective effect of high 25-hydroxyvitamin D levels on clinical outcome.

Who Took Part

The study group was 436 patients.

The age groups tagged for this paper are adults, middle-aged adults and older adults, both men and women.

In a prospective randomized double-blind placebo-controlled trial, 436 patients with resected CM stage IA to III (8th American Joint Committee on Cancer staging) were randomized.

Following randomization, patients were followed for a median of 52 months, with a maximum follow-up of 116 months.

How the Study Was Run

In design terms this was a randomized, double-blind and placebo-controlled study.

Because people in this Vitamin D, K2, Magnesium and Zinc study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Neither the patients nor the staff measuring them knew who was on Vitamin D, K2, Magnesium and Zinc, so expectations could not easily colour the readings.

A placebo (an inactive look-alike) gave the Vitamin D, K2, Magnesium and Zinc group a baseline to be compared against.

The primary endpoint was relapse-free survival.

Secondary endpoints were melanoma-related mortality, overall survival, and the evolution of 25-hydroxyvitamin D serum levels over time.

What Was Measured

Observational studies in cutaneous melanoma (CM) have indicated an inverse relationship between levels of 25-hydroxyvitamin D and Breslow thickness, in addition to a protective effect of high 25-hydroxyvitamin D levels on clinical outcome.

The subject headings attached to it are Melanoma, Skin Neoplasms, Vitamin D, Dietary Supplements, Cholecalciferol, Neoplasm Recurrence, Local and Vitamins.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Vitamin D, K2, Magnesium and Zinc in 436 patients.

With several hundred people or more, it is a fairly large study for this kind of research.

Results are reported in around 6 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2024 (The British journal of dermatology), a journal based in England.

More context: the Vitamin D, K2, Magnesium and Zinc compound page, all human trials.