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

NCT05547750 | Completed

• 1 other identifier: 2022-S17
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nocturnal Leg Cramps

Keywords

Nocturnal Leg Cramps; Vitamin K2; older population

Outcome Measures

Primary Outcomes (1)

• The number of NLCs attacks

  The mean number of NLC attacks per week

  Comparing frequency differences between vitamin K2 and placebo treatment phases of NLCs in a 8 weeks investigation

Secondary Outcomes (2)

• The duration of NLCs

  During the 8 weeks of investigation, the differences in the duration during NLCs attacks will record in the trial compared to vitamin K2- and placebo-treated arms

• The severity of NLCs

  During the 8 weeks of investigation, pain severity during NLCs attacks is recorded in the trial and compared to vitamin K2- and placebo-treated arms

Study Arms (2)

vitamin K2 arm

EXPERIMENTAL

The vitamin K2 arm takes vitamin K2 180 μg/day at bedtime for 8 weeks.

Drug: Vitamin K2

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Vitamin K2 DRUG

Vitamin K2 is a fat-soluble and one of the body's indispensable vitamins. It is mainly synthesized by gut bacteria in the body and plays a role in the mitochondrial electron transport chain. It boosts calcium metabolism, acts on osteoblasts, and promotes bone tissue calcification. It also inhibits osteoclasts from causing bone resorption, thus increasing bone density, and preventing osteoporosis. Furthermore, it regulates the use of calcium and promotes the inhibition of vascular calcification by matrix Gla protein (MGP) activity. Vitamin K2 supplementation at recommended dosage does not affect vitamin K-dependent coagulation factors' activity. It does not enhance the carboxylation of prothrombin in healthy individuals. Vitamin K2 administration does not alter the hemostatic balance in healthy populations without anticoagulation treatment. Thus, vitamin K2 is deemed to have a good safety profile.

vitamin K2 arm

Placebo DRUG

Similar-looking placebo tablets

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Unexplained cramps occurred two or more times in 2 weeks.
• Age ≥65-year-old.

You may not qualify if:

• Cramps caused by specific metabolic diseases and specific neuropathies (hypothyroidism, hemodialysis, hypoglycemia, alcoholism, amyotrophic lateral sclerosis, and poliomyelitis complications, lumbar spinal stenosis, Parkinson's disease, radiculopathies, and motor neuron diseases);
• 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;

Sponsors & Collaborators

• The Third People's Hospital of Chengdu: lead
• Affiliated Hospital of North Sichuan Medical College: collaborator

Study Sites (1)

Chengdu Third People's Hospital

Chengdu, Sichuan, 610000, China

Location

Related Publications (2)

• Tan J, Zhu R, Li Y, Wang L, Liao S, Cheng L, Mao L, Jing D. Vitamin K2 in Managing Nocturnal Leg Cramps: A Randomized Clinical Trial. JAMA Intern Med. 2024 Dec 1;184(12):1443-1447. doi: 10.1001/jamainternmed.2024.5726.

  PMID: 39466236 DERIVED

• Li Y, Zhu R, Wang L, Tan J. Effect of vitamin K2 in the treatment of nocturnal leg cramps in the older population: Study protocol of a randomized, double-blind, controlled trial. Front Nutr. 2023 Feb 23;10:1119233. doi: 10.3389/fnut.2023.1119233. eCollection 2023.

  PMID: 36908924 DERIVED

MeSH Terms

Conditions

Sleep-Wake Transition Disorders

Interventions

Vitamin K 2

Condition Hierarchy (Ancestors)

Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Vitamin K; Naphthoquinones; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phytol; Diterpenes; Terpenes; Quinones; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants will be classified into two intervention groups at a ratio of 1:1, using a computer-generated randomized sequence with varying unknown block sizes for all study centers without stratification. A research assistant not involved in clinical care and participant evaluations will prepare sequentially numbered, opaque, sealed envelopes based on a random list and ensure that anyone will not access or influence the allocation data. The participants, outcome assessor, and statistician will be blinded to group allocation and not involved in the treatment procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of hematology department

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 21, 2022
• Study Start: October 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)