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Low number met criteria to randomize.
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This study intends to investigate the use of high-dose Vitamin D3 plus a multivitamin in the prevention of cluster headache attacks.
Participants can be enrolled anywhere in the United States that has access to one of our participating labs (for blood work - anticipated to be available in most of the USA).
The study may include:
Specifically, our primary outcome is the change from baseline to experimental weeks 1-3 in the frequency of cluster headache attacks between placebo and high-dose vitamin D. Specific primary and secondary outcomes are listed below.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vitamin D+multivitamin | Experimental |
| |
| placebo+multivitamin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Dietary Supplement | Participants will receive vitamin D+multivitamin for 3 weeks. At the end of 3 weeks they will complete an online or paper questionnaire and blood work will be done. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in average weekly frequency of cluster headache attacks | First primary outcome | (baseline, average of weeks 1-3) |
| Change in average weekly frequency of cluster headache attacks | Second primary outcome | (baseline, week 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who had a reduction of at least 50% in the weekly frequency of cluster headache attacks between baseline and week 3 | (baseline, week 3) | |
| Number of participants who had a reduction of at least 30% in the weekly frequency of cluster headache attacks between baseline and week 3 |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Mark J Burish, MD,PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D003027 | Cluster Headache |
| D006261 | Headache |
| D051303 | Trigeminal Autonomic Cephalalgias |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| C067316 | Geritol |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| multivitamin | Dietary Supplement | Participants will receive placebo+multivitamin or vitamin D+multivitamin for 3 weeks. At the end of 3 weeks they will complete an online or paper questionnaire and blood work will be done. |
|
| Placebo | Dietary Supplement | Participants will receive placebo+multivitamin for 3 weeks. At the end of 3 weeks they will complete an online or paper questionnaire and blood work will be done. |
|
| baseline, week 3 |
| Change in number of abortive medications or other treatments used per week | baseline, week 3 |
| Change in intensity of cluster headache attacks as assessed by numerical rating scale | Total score ranges from 0-10, and a higher score indicates a greater intensity of attacks | baseline, week 3 |
| Change in number of participants whose disease is 'much better' or 'very much better' as assessed by the Patient Global Impression of Improvement Scale | With the Patient Global Impression of Improvement Scale, a patient is asked to rate their disease as Very much better, Much better, A little better, No change, A little worse, Much worse, or Very much worse compared to a reference point in the past | baseline, week 3 |
| Change in quality of life as measured by the Cluster Headache Quality of life questionnaire | Total score ranges from 0-100, and a higher score indicates a better quality of life | baseline, week 3 |
| Change in duration of cluster headache attacks, in minutes | baseline, week 3 |
| Change in level of 25-hydroxyvitamin D | baseline, week 3 |
| Change in average weekly frequency of cluster headache attacks | (baseline, week 6) |
| Number of participants who had a reduction of at least 50% in the weekly frequency of cluster headache attacks between baseline and week 6 | (baseline, week 6) |
| Number of participants who had a reduction of at least 30% in the weekly frequency of cluster headache attacks between baseline and week 6 | baseline, week 6 |
| Change in number of abortive medications or other treatments used per week | baseline, week 6 |
| Change in intensity of cluster headache attacks as assessed by numerical rating scale | Total score ranges from 0-10, and a higher score indicates a greater intensity of attacks | baseline, week 6 |
| Change in number of participants whose disease is 'much better' or 'very much better' as assessed by the Patient Global Impression of Improvement Scale | With the Patient Global Impression of Improvement Scale, a patient is asked to rate their disease as Very much better, Much better, A little better, No change, A little worse, Much worse, or Very much worse compared to a reference point in the past | baseline, week 6 |
| Change in quality of life as measured by the Cluster Headache Quality of life questionnaire | Total score ranges from 0-100, and a higher score indicates a better quality of life | baseline, week 6 |
| Change in duration of cluster headache attacks, in minutes | baseline, week 6 |
| Change in level of 25-hydroxyvitamin D | baseline, week 6 |
| Number of days until end of the cluster period after the start of treatment (i.e., the time to the end of an episodic cluster cycle) | upto 3 weeks from treatment |
| Change in average weekly frequency of cluster headache attacks | (baseline, week 2) |
| Change in average weekly frequency of cluster headache attacks | (baseline, week 1) |
| Change in intensity of cluster headache attacks as assessed by numerical rating scale | Total score ranges from 0-10, and a higher score indicates a greater intensity of attacks | baseline, week 2 |
| Change in intensity of cluster headache attacks as assessed by numerical rating scale | Total score ranges from 0-10, and a higher score indicates a greater intensity of attacks | baseline, week 1 |
| Change in duration of cluster headache attacks, in minutes | baseline, week 2 |
| Change in duration of cluster headache attacks, in minutes | baseline, week 1 |
| Change in number of abortive medications or other treatments used per week | baseline, week 2 |
| Change in number of abortive medications or other treatments used per week | baseline, week 1 |
| Change in quality of life as measured by the Cluster Headache Quality of life questionnaire | Total score ranges from 0-100, and a higher score indicates a better quality of life | baseline, week 2 |
| Change in quality of life as measured by the Cluster Headache Quality of life questionnaire | Total score ranges from 0-100, and a higher score indicates a better quality of life | baseline, week 1 |
| Change in level of 25-hydroxyvitamin D | baseline, week 2 |
| Change in level of 25-hydroxyvitamin D | baseline, week 1 |
| Change in level of calcium | baseline, week 3 |
| Change in level of calcium | baseline, week 6 |
| Change in level of calcium | baseline, week 2 |
| Change in level of calcium | baseline, week 1 |
| Change in level of phosphate | baseline, week 3 |
| Change in level of phosphate | baseline, week 6 |
| Change in level of phosphate | baseline, week 1 |
| Change in level of phosphate | baseline, week 2 |
| Change in level of parathyroid hormone | baseline, week 3 |
| Change in level of parathyroid hormone | baseline, week 6 |
| Change in level of parathyroid hormone | baseline, week 1 |
| Change in level of parathyroid hormone | baseline, week 2 |
| Change in level of creatinine | baseline, week 3 |
| Change in level of creatinine | baseline, week 6 |
| Change in level of creatinine | baseline, week 1 |
| Change in level of creatinine | baseline, week 2 |
| Change in number of participants whose disease is 'much better' or 'very much better' as assessed by the Patient Global Impression of Improvement Scale | With the Patient Global Impression of Improvement Scale, a patient is asked to rate their disease as Very much better, Much better, A little better, No change, A little worse, Much worse, or Very much worse compared to a reference point in the past | baseline, week 2 |
| Change in number of participants whose disease is 'much better' or 'very much better' as assessed by the Patient Global Impression of Improvement Scale | With the Patient Global Impression of Improvement Scale, a patient is asked to rate their disease as Very much better, Much better, A little better, No change, A little worse, Much worse, or Very much worse compared to a reference point in the past | baseline, week 1 |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |