![]() The arms would consist of an equal number of participants, and the study would be conducted double-blind between the participants and the researchers during observation. ![]() ![]() ![]() The subjects screened with NLCs will be randomly assigned to two arms: the vitamin K2 arm (vitamin K2 180 μg/day) and the placebo arm. The study will conduct as a randomized controlled, double-blinded trial. This manuscript is according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines ( 18). This prospective, multicenter RCT will recruit participants from two tertiary hospitals, Chengdu Third People’s Hospital and Affiliated Hospital of North Sichuan Medical College, with the diagnosis of NLCs. To further investigate the efficacy and safety of vitamin K2 in NLCs, we designed this prospective, multicenter, randomized, double-blind trial. Our pilot study demonstrated that vitamin K2 supplementation decreases the frequency, duration, and severity of muscle cramps in hemodialysis patients ( 17). In addition, vitamin K2 has a good safety profile compared to other medications. To the best of our knowledge, no study has yet investigated the efficacy of vitamin K in NLCs. Accumulating evidence has shown the beneficial effects of vitamin K2 supplementation on cardiovascular and bone health ( 15).Īnother study revealed that vitamin K3 relieved muscle cramps by effectuating the voltage-dependent calcium channels to release the calcium stored in the cells, thus reducing the frequency of muscular contractions ( 16). In addition to their role in coagulation, vitamin K-dependent proteins are involved in vascular calcification and osteoporosis physiology. It is found in two isoforms (phylloquinone (vitamin K1) and menaquinone (vitamin K2)) that differ in length and degree of saturation of the side chain. Vitamin K is a fat-soluble vitamin involved in carboxylation and activating several dependent proteins. Therefore, seeking new approaches to manage NLCs is imperative. Meta-analysis of some randomized control trials (RCTs) showed that magnesium therapy did not appear to be effective in the treatment of NLCs in the general population, but may have a negligible effect in pregnant women ( 14). However, magnesium administration did not show significant benefits in NLCs in double-blind, placebo-controlled studies ( 12, 13). Magnesium supplements are widely marketed for the prophylaxis of NLCs since a double-blind, placebo-controlled study proved their effectiveness in pregnant women ( 11). Magnesium supplements are often used as a preventative treatment for NLCs ( 7, 8) however, their effectiveness is controversial ( 2, 9, 10). Quinine has been shown to be effective in treating NLCs but is not recommended by the US Food and Drug Administration due to severe side effects ( 6). The cramps can be relieved by passive stretching of the gastrocnemius and deep tissue massage, but such prevention is limited, especially in patients with refractory muscle cramps ( 5). Factors that may lead to leg cramps attacks include hemodialysis, electrolyte imbalance, metabolic disorders, and congenital disorders ( 4). The medical history and physical examination are usually sufficient to differentiate nocturnal leg cramps from other conditions, such as restless legs syndrome, claudication, myositis, and peripheral neuropathy. Patients might wake up with pain during attacks, making it difficult to sleep for a short period. The gastrocnemius is commonly involved ( 1), lasting from a few seconds to a few minutes ( 2). Nocturnal leg cramps (NLCs) are spontaneous contractions of muscles.
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