Efficacy and safety of calcium, magnesium, potassium, and sodium oxybates (lower-sodium oxybate [LXB]; JZP-258) in a placebo-controlled, double-blind, randomized withdrawal study in adults with narcolepsy with cataplexy.

What Was Tested

The paper reports a study of Vitamin D, K2, Magnesium and Zinc, published as a randomized controlled trial.

Who Took Part

By PubMed's age tags, the people studied were teenagers, young adults, adults, middle-aged adults and older adults.

Adults aged 18-70 years with narcolepsy with cataplexy were eligible.

During DBRWP, participants were randomized 1:1 to placebo or to continue LXB treatment.

How the Study Was Run

The design is described as randomized, double-blind, open-label and placebo-controlled.

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

As a double-blind Vitamin D, K2, Magnesium and Zinc study, the assignments were hidden from both participants and investigators until the end.

Everyone knew when Vitamin D, K2, Magnesium and Zinc was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

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

What Was Measured

The subject headings attached to it are Calcium, Cataplexy, Magnesium, Narcolepsy, Potassium, Sodium and Sodium Oxybate.

The authors tagged it with the keywords JZP-258 and excessive daytime sleepiness.

What This Means in Plain Language

The paper is a randomized, double-blind and open-label study of Vitamin D, K2, Magnesium and Zinc.

The abstract goes on to report its results in about 5 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2021 (Sleep), a journal based in United States.

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