High Dose Vitamin D Plus Multivitamin in the Prevention of Cluster Headache
Status:
Recruiting
Trial end date:
2024-06-22
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
The University of Texas Health Science Center, Houston