Cluster HeadacheNCT04570475
High Dose Vitamin D Plus Multivitamin in the Prevention of Cluster Headache
A study testing Vitamin D and multivitamin in people with Cluster Headache, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cluster Headache
- What is being tested?
- Vitamin D and multivitamin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2021to 13 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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:
- 25-hydroxyvitamin D levels >75 nmol/L
- Elevated calcium level
- Elevated phosphate level
- Abnormal parathyroid hormone levels
- Elevated creatinine level
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: High Dose Vitamin D Plus Multivitamin in the Prevention of Cluster Headache: a Randomized, Double-blind, Placebo Controlled Trial.
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).
Read more
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.
- Conditions
- Cluster Headache
- Being tested
- Vitamin D, multivitamin, Placebo
- Keywords
- headache, trigeminal autonomic cephalalgia, chronic cluster headache, episodic cluster headache
- Medical subject headings
- Cluster Headache, Headache, Trigeminal Autonomic Cephalalgias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary 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.
multivitaminDietary 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.
PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| vitamin D+multivitamin | Experimental | Not described Receives: Dietary Supplement: Vitamin D; Dietary Supplement: multivitamin |
| placebo+multivitamin | Active comparator | Not described Receives: Dietary Supplement: multivitamin; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in average weekly frequency of cluster headache attacks
First primary outcome
Measured: (baseline, average of weeks 1-3)
Change in average weekly frequency of cluster headache attacks
Second primary outcome
Measured: (baseline, week 3)
Secondary outcomes (48)
Number of participants who had a reduction of at least 50% in the weekly frequency of cluster headache attacks between baseline and week 3
Measured: (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
Measured: baseline, week 3
Change in number of abortive medications or other treatments used per week
Measured: 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
Measured: 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
Measured: 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
Measured: baseline, week 3
Change in duration of cluster headache attacks, in minutes
Measured: baseline, week 3
Change in level of 25-hydroxyvitamin D
Measured: baseline, week 3
Change in average weekly frequency of cluster headache attacks
Measured: (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
Measured: (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
Measured: baseline, week 6
Change in number of abortive medications or other treatments used per week
Measured: 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
Measured: 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
Measured: 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
Measured: baseline, week 6
Change in duration of cluster headache attacks, in minutes
Measured: baseline, week 6
Change in level of 25-hydroxyvitamin D
Measured: 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)
Measured: upto 3 weeks from treatment
Change in average weekly frequency of cluster headache attacks
Measured: (baseline, week 2)
Change in average weekly frequency of cluster headache attacks
Measured: (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
Measured: 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
Measured: baseline, week 1
Change in duration of cluster headache attacks, in minutes
Measured: baseline, week 2
Change in duration of cluster headache attacks, in minutes
Measured: baseline, week 1
Change in number of abortive medications or other treatments used per week
Measured: baseline, week 2
Change in number of abortive medications or other treatments used per week
Measured: 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
Measured: 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
Measured: baseline, week 1
Change in level of 25-hydroxyvitamin D
Measured: baseline, week 2
Change in level of 25-hydroxyvitamin D
Measured: baseline, week 1
Change in level of calcium
Measured: baseline, week 3
Change in level of calcium
Measured: baseline, week 6
Change in level of calcium
Measured: baseline, week 2
Change in level of calcium
Measured: baseline, week 1
Change in level of phosphate
Measured: baseline, week 3
Change in level of phosphate
Measured: baseline, week 6
Change in level of phosphate
Measured: baseline, week 1
Change in level of phosphate
Measured: baseline, week 2
Change in level of parathyroid hormone
Measured: baseline, week 3
Change in level of parathyroid hormone
Measured: baseline, week 6
Change in level of parathyroid hormone
Measured: baseline, week 1
Change in level of parathyroid hormone
Measured: baseline, week 2
Change in level of creatinine
Measured: baseline, week 3
Change in level of creatinine
Measured: baseline, week 6
Change in level of creatinine
Measured: baseline, week 1
Change in level of creatinine
Measured: 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
Measured: 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
Measured: baseline, week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start15 Sep 2021
- Primary completion13 May 2024
- Study completion13 May 2024
Why it stopped: Low number met criteria to randomize.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cluster HeadacheStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark J Burish, The University of Texas Health Science Center, Houston
- Investigators
- Mark J Burish, MD,PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04570475
- Sponsor's protocol ID
- HSC-MS-20-0945
- Status last verified
- Feb 2025
- First submitted
- 25 Sep 2020
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dose Vitamin D Plus Multivitamin in the Prevention of Cluster Headache: a Randomized, Double-blind, Placebo Controlled Trial.
- ClinicalTrials.gov ID
- NCT04570475
- Acronym / sponsor ID
- HSC-MS-20-0945
- Conditions
- Cluster Headache
- Keywords
- headache, trigeminal autonomic cephalalgia, chronic cluster headache, episodic cluster headache
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low number met criteria to randomize.
- Enrolment
- 27 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 13 May 2024 (actual)
- Study completion
- 13 May 2024 (actual)
- First posted
- 30 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin D+multivitamin | Experimental | Dietary Supplement: Vitamin D, Dietary Supplement: multivitamin |
| placebo+multivitamin | Active comparator | Dietary Supplement: multivitamin, Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DParticipants 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 supplement | vitamin D+multivitamin |
| multivitaminParticipants 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 supplement | placebo+multivitamin, vitamin D+multivitamin |
| PlaceboParticipants 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. | Dietary supplement | placebo+multivitamin |
Primary outcome
Change in average weekly frequency of cluster headache attacks
Time frame: (baseline, average of weeks 1-3)
First primary outcome
Change in average weekly frequency of cluster headache attacks
Time frame: (baseline, week 3)
Second primary outcome
48 secondary outcomes
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)
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
Change in number of abortive medications or other treatments used per week
Time frame: baseline, week 3
Change in intensity of cluster headache attacks as assessed by numerical rating scale
Time frame: 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
Time frame: baseline, week 3
Change in quality of life as measured by the Cluster Headache Quality of life questionnaire
Time frame: baseline, week 3
Change in duration of cluster headache attacks, in minutes
Time frame: baseline, week 3
Change in level of 25-hydroxyvitamin D
Time frame: baseline, week 3
Change in average weekly frequency of cluster headache attacks
Time frame: (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
Time frame: (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
Time frame: baseline, week 6
Change in number of abortive medications or other treatments used per week
Time frame: baseline, week 6
Change in intensity of cluster headache attacks as assessed by numerical rating scale
Time frame: 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
Time frame: baseline, week 6
Change in quality of life as measured by the Cluster Headache Quality of life questionnaire
Time frame: baseline, week 6
Change in duration of cluster headache attacks, in minutes
Time frame: baseline, week 6
Change in level of 25-hydroxyvitamin D
Time frame: 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)
Time frame: upto 3 weeks from treatment
Change in average weekly frequency of cluster headache attacks
Time frame: (baseline, week 2)
Change in average weekly frequency of cluster headache attacks
Time frame: (baseline, week 1)
Change in intensity of cluster headache attacks as assessed by numerical rating scale
Time frame: baseline, week 2
Change in intensity of cluster headache attacks as assessed by numerical rating scale
Time frame: baseline, week 1
Change in duration of cluster headache attacks, in minutes
Time frame: baseline, week 2
Change in duration of cluster headache attacks, in minutes
Time frame: baseline, week 1
Change in number of abortive medications or other treatments used per week
Time frame: baseline, week 2
Change in number of abortive medications or other treatments used per week
Time frame: baseline, week 1
Change in quality of life as measured by the Cluster Headache Quality of life questionnaire
Time frame: baseline, week 2
Change in quality of life as measured by the Cluster Headache Quality of life questionnaire
Time frame: baseline, week 1
Change in level of 25-hydroxyvitamin D
Time frame: baseline, week 2
Change in level of 25-hydroxyvitamin D
Time frame: baseline, week 1
Change in level of calcium
Time frame: baseline, week 3
Change in level of calcium
Time frame: baseline, week 6
Change in level of calcium
Time frame: baseline, week 2
Change in level of calcium
Time frame: baseline, week 1
Change in level of phosphate
Time frame: baseline, week 3
Change in level of phosphate
Time frame: baseline, week 6
Change in level of phosphate
Time frame: baseline, week 1
Change in level of phosphate
Time frame: baseline, week 2
Change in level of parathyroid hormone
Time frame: baseline, week 3
Change in level of parathyroid hormone
Time frame: baseline, week 6
Results and safety
The study was stopped early (reason given: Low number met criteria to randomize.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark J Burish, MD,PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D and multivitamin in people with Cluster Headache, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low number met criteria to randomize.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in average weekly frequency of cluster headache attacks (time frame: (baseline, average of weeks 1-3)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.