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

February 3, 2025 updated by: Mark J Burish, The University of Texas Health Science Center, Houston

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).

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: vitamin D+multivitamin
Dietary supplement: 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.
Dietary supplement: 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
Dietary supplement: 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.
Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in average weekly frequency of cluster headache attacks
Time Frame: (baseline, average of weeks 1-3)
First primary outcome
(baseline, average of weeks 1-3)
Change in average weekly frequency of cluster headache attacks
Time Frame: (baseline, week 3)
Second primary outcome
(baseline, week 3)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
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
Time Frame: (baseline, 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
Time Frame: baseline, week 3
baseline, week 3
Change in number of abortive medications or other treatments used per week
Time Frame: baseline, week 3
baseline, week 3
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
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
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
Time Frame: baseline, week 3
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
Time Frame: baseline, week 3
baseline, week 3
Change in level of 25-hydroxyvitamin D
Time Frame: baseline, week 3
baseline, week 3
Change in average weekly frequency of cluster headache attacks
Time Frame: (baseline, week 6)
(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)
(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
baseline, week 6
Change in number of abortive medications or other treatments used per week
Time Frame: baseline, week 6
baseline, week 6
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
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
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
Time Frame: baseline, week 6
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
Time Frame: baseline, week 6
baseline, week 6
Change in level of 25-hydroxyvitamin D
Time Frame: baseline, week 6
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
upto 3 weeks from treatment
Change in average weekly frequency of cluster headache attacks
Time Frame: (baseline, week 2)
(baseline, week 2)
Change in average weekly frequency of cluster headache attacks
Time Frame: (baseline, week 1)
(baseline, week 1)
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
baseline, week 2
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
baseline, week 1
Change in duration of cluster headache attacks, in minutes
Time Frame: baseline, week 2
baseline, week 2
Change in duration of cluster headache attacks, in minutes
Time Frame: baseline, week 1
baseline, week 1
Change in number of abortive medications or other treatments used per week
Time Frame: baseline, week 2
baseline, week 2
Change in number of abortive medications or other treatments used per week
Time Frame: baseline, week 1
baseline, week 1
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
baseline, week 2
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
baseline, week 1
Change in level of 25-hydroxyvitamin D
Time Frame: baseline, week 2
baseline, week 2
Change in level of 25-hydroxyvitamin D
Time Frame: baseline, week 1
baseline, week 1
Change in level of calcium
Time Frame: baseline, week 3
baseline, week 3
Change in level of calcium
Time Frame: baseline, week 6
baseline, week 6
Change in level of calcium
Time Frame: baseline, week 2
baseline, week 2
Change in level of calcium
Time Frame: baseline, week 1
baseline, week 1
Change in level of phosphate
Time Frame: baseline, week 3
baseline, week 3
Change in level of phosphate
Time Frame: baseline, week 6
baseline, week 6
Change in level of phosphate
Time Frame: baseline, week 1
baseline, week 1
Change in level of phosphate
Time Frame: baseline, week 2
baseline, week 2
Change in level of parathyroid hormone
Time Frame: baseline, week 3
baseline, week 3
Change in level of parathyroid hormone
Time Frame: baseline, week 6
baseline, week 6
Change in level of parathyroid hormone
Time Frame: baseline, week 1
baseline, week 1
Change in level of parathyroid hormone
Time Frame: baseline, week 2
baseline, week 2
Change in level of creatinine
Time Frame: baseline, week 3
baseline, week 3
Change in level of creatinine
Time Frame: baseline, week 6
baseline, week 6
Change in level of creatinine
Time Frame: baseline, week 1
baseline, week 1
Change in level of creatinine
Time Frame: baseline, week 2
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
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
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
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
baseline, week 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center, Houston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mark J Burish, MD,PhD, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 13, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 13, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 25, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 30, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSC-MS-20-0945

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cluster Headache

Clinical Trials on Vitamin D

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings