Effect of Vitamin K2 in the Treatment of Nocturnal Leg Cramps in Older Population

What Was Tested

In this not phased trial, researchers set out to test Vitamin D, K2, Magnesium and Zinc.

Nocturnal leg cramps (NLCs) are sudden contractions of the leg muscles, usually in the posterior calf muscles at night, affecting sleep quality.

Because the precise pathophysiology of NCLs is unclear, different interventions have been proposed.

It had two arms (groups): vitamin K2 arm (experimental) and Placebo (placebo comparator).

The placebo group takes a placebo at bedtime for 8 weeks.

The registry classes the interventions as drug.

More on the Plan

Nocturnal leg cramps (NLCs) are spontaneous contractions of muscles.

The gastrocnemius is commonly involved, lasting from a few seconds to a few minutes.

Patients might wake up with pain during attacks, making it difficult to sleep for a short period.

Factors that may lead to leg cramps attacks include hemodialysis, electrolyte imbalance, metabolic disorders, and congenital disorders.

Who Took Part

The registry lists 200 actual participants took part.

It was open to people of any sex aged from 65 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Unexplained cramps occurred two or more times in 2 weeks.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: suffering from malignant tumors (breast cancer, prostate cancer, lymphoma, and multiple myeloma);; taking diuretics, or vitamin k antagonist;; taking supplements with vitamin k2 within 2 months before enrollment;.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

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

The Vitamin D, K2, Magnesium and Zinc group and the comparison group ran side by side rather than switching.

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

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2022-10-01 with completion listed for 2023-12-31.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The number of NLCs attacks (time frame: Comparing frequency differences between vitamin K2 and placebo treatment phases of NLCs in a 8 weeks investigation).

It also tracked 2 secondary outcomes, for example The duration of NLCs and The severity of NLCs.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Vitamin D, K2, Magnesium and Zinc in 200 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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