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Vitamin D + Multivitamin for Cluster Headaches

Phase 3
Recruiting
Led By Mark J Burish, MD,PhD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of chronic cluster headache according to the International Classification of Headache Disorders 3rd edition with approximately one attack daily
Diagnosis of episodic cluster headache according to the International Classification of Headache Disorders 3rd edition with predictable cluster periods of 6 weeks or greater and approximately one attack daily minimum
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 6
Awards & highlights

Study Summary

This trial is investigating whether high doses of Vitamin D3, plus a multivitamin, can help prevent cluster headaches. People in the US can participate by going to a participating lab for blood work (available in most of the US). The study includes a screening, a baseline period, and an experimental period where participants receive either high doses of Vitamin D3 or a placebo. There is also an open-label period where all participants receive the high doses of Vitamin D3. The primary outcome is the change in frequency of cluster headaches from the baseline to the experimental period.

Who is the study for?
This trial is for people with episodic or chronic cluster headaches, who have predictable attacks and don't plan to change their treatment soon. It's not for those with certain blood disorders, liver failure, high vitamin D levels, or using drugs that affect vitamin D metabolism.Check my eligibility
What is being tested?
The study tests if high-dose Vitamin D3 plus a multivitamin can prevent cluster headache attacks. Participants are randomly given either this combination or a placebo in a blinded phase, followed by all receiving the actual supplements in an open-label phase.See study design
What are the potential side effects?
Potential side effects may include elevated calcium levels which could lead to kidney stones or digestive issues; too much vitamin K might increase clotting risk; and allergic reactions to supplement ingredients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with chronic cluster headaches, experiencing about one attack daily.
Select...
I have been diagnosed with episodic cluster headaches with daily attacks for 6 weeks or more.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Cluster Headache
Change in duration of cluster headache attacks, in minutes
Change in intensity of cluster headache attacks as assessed by numerical rating scale
+13 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: vitamin D+multivitaminExperimental Treatment2 Interventions
Group II: placebo+multivitaminActive Control2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vitamin D
FDA approved
multivitamin
1999
Completed Phase 3
~430

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
904 Previous Clinical Trials
320,777 Total Patients Enrolled
3 Trials studying Cluster Headache
6,871 Patients Enrolled for Cluster Headache
Mark J Burish, MD,PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Media Library

Multivitamin Clinical Trial Eligibility Overview. Trial Name: NCT04570475 — Phase 3
Cluster Headache Research Study Groups: vitamin D+multivitamin, placebo+multivitamin
Cluster Headache Clinical Trial 2023: Multivitamin Highlights & Side Effects. Trial Name: NCT04570475 — Phase 3
Multivitamin 2023 Treatment Timeline for Medical Study. Trial Name: NCT04570475 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial have an age limit?

"The age limit for this study is 18-70."

Answered by AI

What is the total amount of people testing this medication?

"That is accurate. The clinicaltrials.gov website has information revealing that this trial is looking for subjects right now. This specific study was initially posted on September 15th, 2021 and was updated on October 31st, 2022. There is a need for 220 individuals total from 1 location."

Answered by AI

Has the FDA released any statements regarding Vitamin D's safety or efficacy?

"There is some evidence for efficacy and Vitamin d has undergone multiple rounds of testing, so it receives a score of 3 for safety."

Answered by AI

Are new participants still being taken in for this experiment?

"This trial, as indicated by its listing on clinicaltrials.gov, is actively recruiting patients. The trial was first posted on September 15th, 2021 and was last updated on October 31st, 2022."

Answered by AI

Do I fit the bill to join this experiment?

"220 individuals aged 18 to 70 who suffer from cluster headaches are being recruited for this clinical trial. Key requirements for applicants include: a diagnosis of episodic or chronic cluster headache according to the International Classification of Headache Disorders 3rd edition, attacks that last 6 weeks or more (in the case of episodic cluster headaches), and having at least one attack per day. Additionally, participants must not be planning on changing their preventive treatments for cluster headaches in the next six weeks."

Answered by AI

Could you direct me to other research on Vitamin D's benefits?

"Currently, there are 36 clinical trials underway that focus on research Vitamin d. Out of these active studies, 11 have reached Phase 3. The majority of the trial sites for Vitamin D are located in Valdemoro, Madrid; however, there are 91 different locations conducting similar research."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
How old are they?
18 - 65
What site did they apply to?
The University of Texas Health Science Center at Houston
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
High Dose Vitamin D Plus Multivitamin in the Prevention of Cluster Headache
Mark J Burish 2021. "High Dose Vitamin D Plus Multivitamin in the Prevention of Cluster Headache". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04570475.
All > Headache > Vitamin D
~79 spots leftby Nov 2025
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