Risk factors for reporting adverse events and for study withdrawal in a population-based trial of vitamin D supplementation.

What Was Tested

This randomized controlled trial looks at Vitamin D, K2, Magnesium and Zinc.

This analysis aimed to identify baseline risk factors of reporting an adverse event in a multi-year randomized double-blinded placebo-controlled trial of vitamin D supplementation.

Median follow-up was 3.3 years.

Who Took Part

The study group was 5110 adults.

By PubMed's age tags, the people studied were middle-aged adults, older adults and people over 80, both men and women.

How the Study Was Run

The researchers set it up as a randomized, double-blind and placebo-controlled study.

The adults were allocated by chance, so the Vitamin D, K2, Magnesium and Zinc group and the comparison group should start out alike.

Blinding on both sides kept the adults and researchers unaware of who received Vitamin D, K2, Magnesium and Zinc.

Some adults received a placebo instead of Vitamin D, K2, Magnesium and Zinc, giving a reference point.

What Was Measured

Topics PubMed links to this paper include Dietary Supplements, Drug-Related Side Effects and Adverse Reactions, Incidence, Risk Factors, Vitamin D, Vitamins and Withholding Treatment.

The authors tagged it with the keywords Adverse events, Longitudinal analysis, Vitamin D supplementation and Withdrawals.

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 5110 adults.

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

The publication is from 2020 (The Journal of steroid biochemistry and molecular biology), a journal based in England.

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