Vitamin K2 Supplementation in Adult Episodic Migraine

What Was Tested

The trial (not phased) is built around Vitamin D, K2, Magnesium and Zinc for migraine.

Migraine is a debilitating illness and a major cause of disability in the world.

It is highly prevalent, especially among women.

Vitamin supplementation is a potential therapeutic option for migraines that remains largely under-explored.

It had two arms (groups): Intervention (MK7) Arm (experimental) and Control Arm (placebo comparator).

This corresponds to the sub-group of subjects who will receive the supplement (vitamin K2 or Menaquinone-7).

This corresponds to the sub-group of subjects who will receive placebo.

The registry classes the interventions as dietary supplement and other.

Who Took Part

The registry lists 160 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adults aged 18 years or above. 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.

The full record lists 5 inclusion and 21 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The migraine participants were allocated by chance, so the Vitamin D, K2, Magnesium and Zinc group and the comparison group should start out alike.

Groups ran in parallel: each of the migraine participants stayed in one arm throughout.

As a double-blind Vitamin D, K2, Magnesium and Zinc study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2024-03-06 with completion listed for 2026-09.

It ran at 1 site in Lebanon.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Changes of monthly migraine days (time frame: 6 months).

It also tracked 6 secondary outcomes, for example Changes from baseline in the headache impact score (HIT-6) as compared to placebo, Changes from baseline in monthly severe migraine days, Changes from baseline on the modified migraine disability assessment (MIDAS) score as compared to placebo, Changes from baseline on the modified migraine physical function impact diary (MPFID) as compared to placebo, Changes from baseline on the quality of life as measure by the EuroQoL compared to placebo and Changes from baseline of arterial stiffness level.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Vitamin D, K2, Magnesium and Zinc in 160 people with migraine.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Vitamin D, K2, Magnesium and Zinc compound page, Migraine research.