Vitamin K2 for Nocturnal Leg Cramps
Trial question
What is the role of vitamin K2 supplementation in patients with nocturnal leg cramps?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
54.0% female
46.0% male
N = 199
199 patients (108 female, 91 male).
Inclusion criteria: community-dwelling adults ≥ 65 years of age with ≥ 2 documented episodes of nocturnal leg cramps in the past 2 weeks.
Key exclusion criteria: cramps caused by specific metabolic diseases or neuropathies; malignant tumors; use of diuretics, VKA, or vitamin K2 in the past 2 months.
Interventions
N=103 vitamin K2 (at a dose of 180 mcg daily for 8 weeks).
N=96 placebo (matching placebo capsule daily for 8 weeks).
Primary outcome
Mean frequency of nocturnal leg cramps
0.96
3.63
3.6 per week
2.7 per week
1.8 per week
0.9 per week
0.0 per week
Vitamin
K2
Placebo
Significant
decrease ▼
Significant decrease in mean frequency of nocturnal leg cramps (0.96 per week vs. 3.63 per week; MD -2.67, 95% CI -2.86 to -2.49).
Secondary outcomes
Significant decrease in mean duration of nocturnal leg cramps (0.25 mins vs. 0.98 mins; MD -0.73, 95% CI -0.8 to -0.65).
Significant decrease in mean severity of nocturnal leg cramps (1.12 points vs. 2.08 points; MD -0.97, 95% CI -1.14 to -0.79).
Conclusion
In community-dwelling adults ≥ 65 years of age with ≥ 2 documented episodes of nocturnal leg cramps in the past 2 weeks, vitamin K2 was superior to placebo with respect to mean frequency of nocturnal leg cramps.
Reference
Jing Tan, Rui Zhu, Ying Li et al. Vitamin K2 in Managing Nocturnal Leg Cramps: A Randomized Clinical Trial. JAMA Intern Med. 2024 Dec 1;184(12):1443-1447.
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