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NCT05547750

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

Completed NA Last updated 17 January 2025
What this trial tests

NA trial testing Vitamin K2 in Nocturnal Leg Cramps in 200 participants. Completed in 31 December 2023.

Timeline
1 October 2022
Primary endpoint
31 December 2023
31 December 2023

Quick facts

Lead sponsorThe Third People's Hospital of Chengdu
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment200
Start date1 October 2022
Primary completion31 December 2023
Estimated completion31 December 2023
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

The Third People's Hospital of Chengdu

Who can join

65 and older, any sex, with Nocturnal Leg Cramps. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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. There is conflicting evidence regarding the efficacy of conventional interventions in preventing cramps. Thus, the present study aims to investigate the effects of vitamin K2 for NLCs in a prospective randomized, double-blind, controlled trial.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Vitamin K2 in Managing Nocturnal Leg Cramps: A Randomized Clinical Trial.
    Tan J, Zhu R, Li Y, Wang L, et al · · 2024 · cited 8× · PMID 39466236 · DOI 10.1001/jamainternmed.2024.5726
  2. Effect of vitamin K2 in the treatment of nocturnal leg cramps in the older population: Study protocol of a randomized, double-blind, controlled trial.
    Li Y, Zhu R, Wang L, Tan J. · · 2023 · cited 1× · PMID 36908924 · DOI 10.3389/fnut.2023.1119233

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Other trials of Vitamin K2

Trials testing the same drug.

Other The Third People's Hospital of Chengdu trials

Trials by the same sponsor.

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