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

Cluster Headache Clinical Trial

Official title:
High Dose Vitamin D Plus Multivitamin in the Prevention of Cluster Headache: a Randomized, Double-blind, Placebo Controlled Trial.

Clinical 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). 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04570475
Study type Interventional
Source The University of Texas Health Science Center, Houston
Contact Mark J Burish, MD,PhD
Phone (713) 486-7771
Email nctt.wec@uth.tmc.edu
Status Recruiting
Phase Phase 3
Start date September 15, 2021
Completion date June 22, 2026
View Details
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