Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04570475
Recruitment Status : Not yet recruiting
First Posted : September 30, 2020
Last Update Posted : April 29, 2021
Sponsor:
Information provided by (Responsible Party):
Mark J Burish, The University of Texas Health Science Center, Houston

Brief Summary:

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:

  • Screening: Participants may be interviewed, examined, fill out surveys, and get blood testing
  • Week 1: baseline period (no added medications - to establish a baseline)
  • Weeks 2-4: double-blinded experimental period - participants receive either 1) high-dose Vitamin D3 + multivitamin, or 2) placebo + multivitamin. Participants also fill out a survey and have blood testing.
  • Weeks 5-7: open-label period - ALL participants receive high-dose Vitamin D3 + multivitamin. Participants also fill out a survey and may have blood testing.

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.


Condition or disease Intervention/treatment Phase
Cluster Headache Drug: Vitamin D Drug: multivitamin Drug: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: High Dose Vitamin D Plus Multivitamin in the Prevention of Cluster Headache: a Randomized, Double-blind, Placebo Controlled Trial.
Estimated Study Start Date : May 30, 2021
Estimated Primary Completion Date : September 22, 2023
Estimated Study Completion Date : June 22, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Vitamin D

Arm Intervention/treatment
Experimental: vitamin D+multivitamin Drug: Vitamin D
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.

Drug: multivitamin
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.

Active Comparator: placebo+multivitamin Drug: multivitamin
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.

Drug: Placebo
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.




Primary Outcome Measures :
  1. Change in average weekly frequency of cluster headache attacks [ Time Frame: (baseline, average of weeks 1-3) ]
    First primary outcome

  2. Change in average weekly frequency of cluster headache attacks [ Time Frame: (baseline, week 3) ]
    Second primary outcome


Secondary Outcome Measures :
  1. Number of participants who had a reduction of at least 50% in the weekly frequency of cluster headache attacks between baseline and week 3 [ Time Frame: (baseline, week 3) ]
  2. Number of participants who had a reduction of at least 30% in the weekly frequency of cluster headache attacks between baseline and week 3 [ Time Frame: baseline, week 3 ]
  3. Change in number of abortive medications or other treatments used per week [ Time Frame: baseline, week 3 ]
  4. Change in intensity of cluster headache attacks as assessed by numerical rating scale [ Time Frame: baseline, week 3 ]
    Total score ranges from 0-10, and a higher score indicates a greater intensity of attacks

  5. Change in number of participants whose disease is 'much better' or 'very much better' as assessed by the Patient Global Impression of Improvement Scale [ Time Frame: baseline, week 3 ]
    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

  6. Change in quality of life as measured by the Cluster Headache Quality of life questionnaire [ Time Frame: baseline, week 3 ]
    Total score ranges from 0-100, and a higher score indicates a better quality of life

  7. Change in duration of cluster headache attacks, in minutes [ Time Frame: baseline, week 3 ]
  8. Change in level of 25-hydroxyvitamin D [ Time Frame: baseline, week 3 ]
  9. Change in average weekly frequency of cluster headache attacks [ Time Frame: (baseline, week 6) ]
  10. Number of participants who had a reduction of at least 50% in the weekly frequency of cluster headache attacks between baseline and week 6 [ Time Frame: (baseline, week 6) ]
  11. Number of participants who had a reduction of at least 30% in the weekly frequency of cluster headache attacks between baseline and week 6 [ Time Frame: baseline, week 6 ]
  12. Change in number of abortive medications or other treatments used per week [ Time Frame: baseline, week 6 ]
  13. Change in intensity of cluster headache attacks as assessed by numerical rating scale [ Time Frame: baseline, week 6 ]
    Total score ranges from 0-10, and a higher score indicates a greater intensity of attacks

  14. Change in number of participants whose disease is 'much better' or 'very much better' as assessed by the Patient Global Impression of Improvement Scale [ Time Frame: baseline, week 6 ]
    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

  15. Change in quality of life as measured by the Cluster Headache Quality of life questionnaire [ Time Frame: baseline, week 6 ]
    Total score ranges from 0-100, and a higher score indicates a better quality of life

  16. Change in duration of cluster headache attacks, in minutes [ Time Frame: baseline, week 6 ]
  17. Change in level of 25-hydroxyvitamin D [ Time Frame: baseline, week 6 ]
  18. 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) [ Time Frame: upto 3 weeks from treatment ]
  19. Change in average weekly frequency of cluster headache attacks [ Time Frame: (baseline, week 2) ]
  20. Change in average weekly frequency of cluster headache attacks [ Time Frame: (baseline, week 1) ]
  21. Change in intensity of cluster headache attacks as assessed by numerical rating scale [ Time Frame: baseline, week 2 ]
    Total score ranges from 0-10, and a higher score indicates a greater intensity of attacks

  22. Change in intensity of cluster headache attacks as assessed by numerical rating scale [ Time Frame: baseline, week 1 ]
    Total score ranges from 0-10, and a higher score indicates a greater intensity of attacks

  23. Change in duration of cluster headache attacks, in minutes [ Time Frame: baseline, week 2 ]
  24. Change in duration of cluster headache attacks, in minutes [ Time Frame: baseline, week 1 ]
  25. Change in number of abortive medications or other treatments used per week [ Time Frame: baseline, week 2 ]
  26. Change in number of abortive medications or other treatments used per week [ Time Frame: baseline, week 1 ]
  27. Change in quality of life as measured by the Cluster Headache Quality of life questionnaire [ Time Frame: baseline, week 2 ]
    Total score ranges from 0-100, and a higher score indicates a better quality of life

  28. Change in quality of life as measured by the Cluster Headache Quality of life questionnaire [ Time Frame: baseline, week 1 ]
    Total score ranges from 0-100, and a higher score indicates a better quality of life

  29. Change in level of 25-hydroxyvitamin D [ Time Frame: baseline, week 2 ]
  30. Change in level of 25-hydroxyvitamin D [ Time Frame: baseline, week 1 ]
  31. Change in level of calcium [ Time Frame: baseline, week 3 ]
  32. Change in level of calcium [ Time Frame: baseline, week 6 ]
  33. Change in level of calcium [ Time Frame: baseline, week 2 ]
  34. Change in level of calcium [ Time Frame: baseline, week 1 ]
  35. Change in level of phosphate [ Time Frame: baseline, week 3 ]
  36. Change in level of phosphate [ Time Frame: baseline, week 6 ]
  37. Change in level of phosphate [ Time Frame: baseline, week 1 ]
  38. Change in level of phosphate [ Time Frame: baseline, week 2 ]
  39. Change in level of parathyroid hormone [ Time Frame: baseline, week 3 ]
  40. Change in level of parathyroid hormone [ Time Frame: baseline, week 6 ]
  41. Change in level of parathyroid hormone [ Time Frame: baseline, week 1 ]
  42. Change in level of parathyroid hormone [ Time Frame: baseline, week 2 ]
  43. Change in level of creatinine [ Time Frame: baseline, week 3 ]
  44. Change in level of creatinine [ Time Frame: baseline, week 6 ]
  45. Change in level of creatinine [ Time Frame: baseline, week 1 ]
  46. Change in level of creatinine [ Time Frame: baseline, week 2 ]
  47. Change in number of participants whose disease is 'much better' or 'very much better' as assessed by the Patient Global Impression of Improvement Scale [ Time Frame: baseline, week 2 ]
    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

  48. Change in number of participants whose disease is 'much better' or 'very much better' as assessed by the Patient Global Impression of Improvement Scale [ Time Frame: baseline, week 1 ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04570475


Contacts
Layout table for location contacts
Contact: Mark J Burish, MD,PhD (713) 486-7771 nctt.wec@uth.tmc.edu
Contact: Rebecca Martinez, RN (713) 486-7771 nctt.wec@uth.tmc.edu

Locations
Layout table for location information
United States, Texas
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Contact: Mark J Burish, MD,PhD    713-486-7771    nctt.wec@uth.tmc.edu   
Contact: Rebecca Martinez, RN    (713) 486-7771    nctt.wec@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Layout table for investigator information
Principal Investigator: Mark J Burish, MD,PhD The University of Texas Health Science Center, Houston
Layout table for additonal information
Responsible Party: Mark J Burish, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT04570475    
Other Study ID Numbers: HSC-MS-20-0945
First Posted: September 30, 2020    Key Record Dates
Last Update Posted: April 29, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Mark J Burish, The University of Texas Health Science Center, Houston:
headache
trigeminal autonomic cephalalgia
chronic cluster headache
episodic cluster headache
Additional relevant MeSH terms:
Layout table for MeSH terms
Cluster Headache
Headache
Pain
Neurologic Manifestations
Trigeminal Autonomic Cephalalgias
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vitamin D
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents