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

NCT04570475 | Terminated DMC

• 1 other identifier: HSC-MS-20-0945
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Cluster Headache

Keywords

headache; trigeminal autonomic cephalalgia; chronic cluster headache; episodic cluster headache

Outcome Measures

Primary Outcomes (2)

• Change in average weekly frequency of cluster headache attacks

  First primary outcome

  (baseline, average of weeks 1-3)

• Change in average weekly frequency of cluster headache attacks

  Second primary outcome

  (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

  (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

  baseline, week 3

• Change in number of abortive medications or other treatments used per week

  baseline, week 3

• Change in intensity of cluster headache attacks as assessed by numerical rating scale

  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

  baseline, week 3

Study Arms (2)

vitamin D+multivitamin

EXPERIMENTAL

Dietary Supplement: Vitamin D; Dietary Supplement: multivitamin

placebo+multivitamin

ACTIVE COMPARATOR

Dietary Supplement: multivitamin; Dietary Supplement: Placebo

Interventions

Vitamin D DIETARY_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.

vitamin D+multivitamin

multivitamin DIETARY_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.

placebo+multivitamin; vitamin D+multivitamin

Placebo DIETARY_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.

placebo+multivitamin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• hydroxyvitamin D levels \>75 nmol/L
• Elevated calcium level
• Elevated phosphate level

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Cluster Headache; Headache; Trigeminal Autonomic Cephalalgias

Interventions

Vitamin D; Geritol

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Mark J Burish, MD,PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: September 30, 2020
• Study Start: September 15, 2021
• Primary Completion: May 13, 2024
• Study Completion: May 13, 2024
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)