Effect of Vitamin K2 in the Treatment of Nocturnal Leg Cramps in the Elderly

• Status: Not yet recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Nocturnal leg cramps are a frequent involuntary painful contraction of muscle among the elderly. These often have an important impact on the quality of sleep. Different medication and non-drug treatments have been proposed to treat these cramps, but none to date have been shown to be both safe and effective. Vitamin K2 has been shown effective to reduce frequency, severity, and duration of dialysis related muscle cramps with good safety profile in the recent RCT study. This is first RCT trial to investigate the effectiveness of vitamin K2 in NLCs in the elderly.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ying Li
• Collaborator: Affiliated Hospital of North Sichuan Medical College
• Treatments: Vitamin K; Vitamin K 2

Criteria

Inclusion Criteria:

1. Unexplained cramps occurred two or more times in 2 weeks.

2. Age ≥65-year-old.

Exclusion Criteria:

1. Cramps caused by specific metabolic diseases (hypothyroidism, hemodialysis, amyotrophic lateral sclerosis, and poliomyelitis complications)

2. Suffering from malignant tumors (breast cancer, prostate cancer, lymphoma, and multiple myeloma)

3. Taking diuretics

4. Muscle cramps caused by lumbar spinal stenosis

5. Cirrhosis of the liver requires the release of ascites

6. Undergoing hemodialysis

7. Receiving vitamin K antagonist