Clinical study on the use of high-dose vitamin D3 for the prevention of cluster headache with patient recruitment

Newswise – A clinical study investigating whether high-dose vitamin D3 supplements combined with a multivitamin can be effective in preventing cluster headaches is now recruiting patients at the University of Texas Health Science Center at Houston (UTHealth Houston).

Led by Mark Burish, MD, PhD, Assistant Professor in the Vivian L. Smith Department of Neurosurgery at McGovern Medical School at UTHealth Houston, the study was inspired by feedback from Cluster Busters, a patient-led support group whose members have suffered from cluster headache attacks.

“Members of the Cluster Busters group took high-dose vitamin D supplements for other medical problems and said it worked for their cluster headaches, so I got interested,” said Burish, who is also a pain management specialist at UTHealth Neurosciences and a . is a faculty member of the University of Texas MD Anderson Cancer Center UHealth Graduate School of Biomedical Sciences. “This is how many headache relievers were discovered; For example, we don’t think migraines is a muscle condition, but people who have had migraines were given botox for cosmetic reasons and found it helped with their migraines. We test what patients might find helpful. “

Cluster headaches, which occur in cyclical patterns known as cluster periods, are more painful than childbirth or kidney stones, according to a recent study by Burish and several other researchers. A cluster headache usually wakes a person in the middle of the night with excruciating pain in or around the eye on one side of the head, with a single attack lasting anywhere from 15 minutes to three hours. Most attacks happen at the same time each day.

First, those who sign up for Burish’s study go through a screening process that includes an interview, exam, survey response, and a complete blood count.

The process takes seven weeks. The first week of the study is a baseline phase with no additional medication. The second to fourth week is a double-blind trial phase in which the participants receive either high-dose vitamin D3 plus a multivitamin or a placebo plus a multivitamin. During this time, participants complete a survey and undergo blood tests.

The fifth to seventh week is an open label phase in which all participants receive high-dose vitamin D3 and a multivitamin.

At the end of the seven-week period, Burish measures the changes in the average weekly frequency of cluster headache attacks in participants who received the high-dose vitamin D3 versus placebo for each patient, along with other results.

“Cluster headache is such an under-researched disease, but it is an extremely painful condition,” said Burish, noting a previous study that showed that more than 50% of people who had the seizures had thoughts of suicide. “But based on previous research, vitamin D appears to block CGRP, a pain-signaling molecule that is common in migraines and cluster headaches, so we see a lot of promise in that.”

In total, Burish is looking for around 220 study participants. To be eligible for inclusion, participants must be between 18 and 70 years old and have a diagnosis of episodic or chronic cluster headache. You also need to have predictable cluster periods lasting at least six weeks, with at least one attack per day.

Participants can be enrolled in any location in the US that has access to a participating blood testing laboratory. For more information about the study, visit the clinical study publication or call Rebecca Martinez, RN at 713-486-7771.

The study, which is expected to last until mid-2024, is funded by the Erwin family.