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

This is an interventional treatment trial for Cluster Headache focused on measuring headache, trigeminal autonomic cephalalgia, chronic cluster headache, episodic cluster headache Read More

Inclusion Criteria:

• A diagnosis of episodic cluster headache according to the International Classification of Headache Disorders 3rd edition as well as cluster periods that are predictable and have a duration of 6 weeks or greater and approximately one attack daily minimum OR
• A diagnosis of chronic cluster headache according to the International Classification of Headache Disorders 3rd edition as well as approximately one attack daily
• Participants who are unlikely to need to change their preventive cluster headache treatment regimen in the next 6 weeks.

Exclusion Criteria:

• Co-existing disease or other characteristic that precludes appropriate diagnosis of cluster headache.
• Active drug or alcohol use or dependence that, in the opinion of the site investigator,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 days of the beginning of the study.
• Concurrent use of Vitamin D and/or multivitamin along with the inability to stop them before the study begins.
• Liver failure or known coagulation disorder (as this study includes vitamin K) such as haemophilia, von Willebrand disease, Factor V Leiden, Antithrombin III deficiency, Protein C or S deficiency, or anti-phospholipid antibody syndrome.
• A personal medical history of more than 1 deep venous thrombosis and/or pulmonary embolism (as this study includes vitamin K).
• Current use of anticoagulants (as this study includes vitamin K). Anticoagulants include: 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, including steroids,interferon, phenytoin, phenobarbital, digitalis/digoxin, and thiazide diuretics (such as hydrochlorothiazide or chlorthalidone)

• Participants who are aware that their most recent labwork in the last 2 years showed any 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 is inside the acceptable range for the study. For example, if a candididate were taking a vitamin or medication that may have caused these elevated levels, but no longer take the vitamin or medication, they may be enrolled if retesting is normal.