LBCTR2023075403Not yet recruiting未知
Vitamin K2 Supplementation in Adult Episodic Migraine
Sola Aoun Bahous0 sites160 target enrollmentStarted: February 6, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 160
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 to 100 (—)
- Sex
- All
Inclusion Criteria
- •adults subjects, history of episodic migraine with or without aura since > 12 months according to the ICHD-3 criteria, migraine frequency from 4-14 days per month over the 3 months prior to screening, migraine frequency from 4-14 days per month during the baseline period of assessment, successful completion of the migraine diary during the baseline evaluation period.
Exclusion Criteria
- •migraine patients with superimposed tension type or other forms of primary headaches, patients who are currently on any of the migraine prophylactic treatments (sodium valproate, topiramate, beta-blockers, tricyclic antidepressants, SRNI, flunarizine, verapamil, lisinopril, candesartan), patients who have been on any of the previously listed medications within 3 months of screening, patients who take the following medications: ergotamine or triptans > 10 days per month, NSAIDs or paracetamol > 15 days per month, opioids more than 4 days per month, patients on oral vitamin K antagonists, other active chronic pain syndromes (i.e. fibromyalgia, painful peripheral neuropathy, postherpetic neuralgia…), history of hypersensitivity to the vitamin K2, history of soy protein allergy, history of thrombotic events, diagnosed coagulopathy, cardiovascular event in the past month, current or planned pregnancy, lactation, inability to tolerate oral medications, known intestinal malabsorption or hypomotility syndromes, atrial fibrillation, active malignancy. or acute illness in the past month.
Investigators
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