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Topical Area: Protocols

Protocols (Poster Session)

(P22-048-23) Effect of Vitamin K2 in the Treatment of Nocturnal Leg Cramps in Older Population: Study Protocol of a Randomized, Double-Blind, Crossover-Controlled Trial

Sunday, July 23, 2023
11:45 AM – 12:45 PM ET
Location: Poster Board 413

    Presenting Author(s)

  • Jing Tan

    Director
    Chengdu Third People's Hospital
    Chengdu, Sichuan, China (People's Republic)

    • Co-Author(s)

  • YL

    Ying Li

    School of Clinical Medicine, North Sichuan Medical College

  • RZ

    Rui Zhu

    School of Clinical Medicine, North Sichuan Medical College

  • LW

    Li Wang

    Affiliated Hospital of North Sichuan Medical College

Disclosure(s):
Jing Tan: No relevant financial relationship(s) with ineligible companies to disclose.


Objectives: To investigate the potential efficacy and safety of vitamin K2 in the treatment of nocturnal leg cramps in older population.

Methods: This multicenter, randomized, double-blind, placebo-controlled clinical study will enroll older age (≥65-year-old) with two or more documented episodes of NLCs during 2 weeks of screening). Participants will be randomized to receive vitamin K2 or a similar-looking placebo for 8-week in a 1:1 ratio. Follow-up visits will be scheduled each week. The primary outcome is the difference in the mean number of NLCs per week in the vitamin K2 and placebo arms. The secondary outcomes include the severity and duration of NLCs in the vitamin K2 and placebo arms. The target sample size of 200 provided 90% statistical power with two-sided alpha of 0.05 to detect a mean difference of 0.12% (as percent of total fatty acid) in frequency between randomized groups.
Clinical trial registration: (www.ClinicalTrials.gov), identifier (NCT05547750).

Results: Not available for this study protocol

Conclusions: This is the first randomized controlled trial of rigorous methodological design to investigate effectiveness of vitamin K2 for management of NCLs in older population.

Funding Sources: This work was supported by the China Health Promotion Foundation. This study was a non-profit academic clinical research study.