High Dose Vitamin D Plus Multivitamin in the Prevention of Cluster Headache

Inclusion Criteria:

• A diagnosis of episodic cluster headache according to the InternationalClassification of Headache Disorders 3rd edition as well as cluster periods that arepredictable and have a duration of 6 weeks or greater and approximately one attackdaily minimum OR

• A diagnosis of chronic cluster headache according to the InternationalClassification of Headache Disorders 3rd edition as well as approximately one attackdaily

• Participants who are unlikely to need to change their preventive cluster headachetreatment regimen in the next 6 weeks.

Exclusion Criteria:

• Co-existing disease or other characteristic that precludes appropriate diagnosis ofcluster headache.

• Active drug or alcohol use or dependence that, in the opinion of the siteinvestigator,would interfere with adherence to study requirements.

• Inability or unwillingness of subject to give informed consent.

• Known allergy to study drug, multivitamin, or placebo components

• Pregnancy or lactation (breastfeeding)

• Usage of greater than 4,000 International Units of Vitamin D3 daily within 60 daysof the beginning of the study.

• Concurrent use of Vitamin D and/or multivitamin along with the inability to stopthem before the study begins.

• Liver failure or known coagulation disorder (as this study includes vitamin K) suchas haemophilia, von Willebrand disease, Factor V Leiden, Antithrombin IIIdeficiency, Protein C or S deficiency, or anti-phospholipid antibody syndrome.

• A personal medical history of more than 1 deep venous thrombosis and/or pulmonaryembolism (as this study includes vitamin K).

• Current use of anticoagulants (as this study includes vitamin K). Anticoagulantsinclude: apixaban (Eliquis), betrixaban (Bevyxxa), dabigatran (Pradaxa), dalteparin (Fragmin), edoxaban (Savaysa), enoxaparin (Lovenox), fondaparinux (Arixtra),heparin, rivaroxiban (Xarelto), and warfarin (Coumadin).

• Current use of medications that alter vitamin D metabolism, includingsteroids,interferon, phenytoin, phenobarbital, digitalis/digoxin, and thiazidediuretics (such as hydrochlorothiazide or chlorthalidone)

• Participants who are aware that their most recent labwork in the last 2 years showedany of the following:

1. 25-hydroxyvitamin D levels >75 nmol/L

2. Elevated calcium level

3. Elevated phosphate level

4. Abnormal parathyroid hormone levels

5. Elevated creatinine level

6. Of note if any values are outside the acceptable range for the study,candidates may still participate in the study if the most recent lab testing isinside the acceptable range for the study. For example, if a candididate weretaking a vitamin or medication that may have caused these elevated levels, butno longer take the vitamin or medication, they may be enrolled if retesting isnormal.