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TerminatedNCT04570475Updated Feb 6, 2025

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

An interventional study of Vitamin D and multivitamin in Cluster Headache, sponsored by The University of Texas Health Science Center, Houston. Terminated at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-02-06.

Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Treatment

Why this study was terminated
Low number met criteria to randomize.
Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cluster Headache

Keywords

  • headache
  • trigeminal autonomic cephalalgia
  • chronic cluster headache
  • episodic cluster headache
03

In context

Cluster Headache

123 studies on the registry are indexed under Cluster Headache; 26 are open to participants now.

This study's enrollment of 27 is below the median of 42 across 90 interventional studies indexed under Cluster Headache.

Browse Cluster Headache studies →

Lead sponsor

The University of Texas Health Science Center, Houston is the lead sponsor of 897 studies on the registry; 214 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.

Browse The University of Texas Health Science Center, Houston studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 .
  • 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 ,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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
27 participants (actual)

Study arms

  • Experimental
    vitamin D+multivitamin

    Dietary Supplement: Vitamin D · Dietary Supplement: multivitamin

  • Active comparator
    placebo+multivitamin

    Dietary Supplement: multivitamin · Dietary Supplement: Placebo

Interventions

  • Dietary supplementVitamin 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.

  • Dietary supplementmultivitamin

    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.

  • Dietary supplementPlacebo

    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.

06

What researchers measure

Primary outcomes

  1. Change in average weekly frequency of cluster headache attacks

    First primary outcome

    Time frame: (baseline, average of weeks 1-3)

  2. Change in average weekly frequency of cluster headache attacks

    Second primary outcome

    Time frame: (baseline, week 3)

Secondary outcomes

  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

    Total score ranges from 0-10, and a higher score indicates a greater intensity of attacks

    Time frame: baseline, week 3

  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

    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

    Time frame: baseline, week 3

  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

    Time frame: baseline, week 3

  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

    Total score ranges from 0-10, and a higher score indicates a greater intensity of attacks

    Time frame: baseline, week 6

  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

    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

    Time frame: baseline, week 6

  15. 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

    Time frame: baseline, week 6

  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

    Total score ranges from 0-10, and a higher score indicates a greater intensity of attacks

    Time frame: baseline, week 2

  22. 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

    Time frame: baseline, week 1

  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

    Total score ranges from 0-100, and a higher score indicates a better quality of life

    Time frame: baseline, week 2

  28. 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

    Time frame: baseline, week 1

  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

    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

    Time frame: baseline, week 2

  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

    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

    Time frame: baseline, week 1

07

Study locations

1 site
  • The University of Texas Health Science Center at Houston
    Houston, Texas 77030, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2021 to primary completion in May 2024, 31 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 25, 2020
First posted
Sep 30, 2020
StartActual
Sep 15, 2021
Primary completionActual
May 13, 2024
CompletionActual
May 13, 2024
Last update
Feb 6, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04570475
Lead sponsor
The University of Texas Health Science Center, Houston
Responsible party
Mark J Burish (Assistant Professor, The University of Texas Health Science Center, Houston) — Principal investigator
First posted
Sep 30, 2020
Start date
Sep 15, 2021
Primary completion
May 13, 2024
Completion
May 13, 2024
Last update
Feb 6, 2025

Study contacts

Mark J Burish, MD,PhD
principal investigator · The University of Texas Health Science Center, Houston

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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