Vitamin D Supplementation in Episodic and Chronic Tension-type Headache (NCT05860062) | Clinical Trial Compass
UnknownNot Applicable
Vitamin D Supplementation in Episodic and Chronic Tension-type Headache
Mexico20 participantsStarted 2023-04-18
Plain-language summary
The goal of this clinical trial is to learn about the effect of vitamin D in patients with prophylactic therapy for episodic and chronic tension-type headache in amitriptyline or topiramate treatment. The main question it aims to answer are:
• What is the effect of vitamin D in patients with prophylactic therapy for episodic and chronic tension-type headache?
Patients will have the next selection criteria:
* Patients diagnosed by a neurologist in the headache clinic
* Criteria for episodic and chronic tension-type headache
* Poor clinical response to prophylactic treatment (amitriptyline, topiramate)
* Use of at least 1 prophylactic medication or a history of having used them.
* Onset of disease between the ages of 18 and 60
* Signature of informed consent
The population will be randomly divided into the following 3 treatment groups:
* Participants amitriptyline or topiramate treatment.
* Patients with placebo (Calcium) + topiramate/amitriptyline,
* Participants with vitamin D3/calcium+topiramate/amitriptyline. Researchers will compare the groups to see if vitamin D can decrease the intensity of your headache and therefore have a new therapeutic option.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients diagnosed by a neurologist in the headache clinic
* Criteria for episodic and chronic tension-type headache
* Poor clinical response to prophylactic treatment (amitriptyline, topiramate)
* Use of at least 1 prophylactic medication or a history of having used them.
* Onset of disease between the ages of 18 and 60
* Signature of informed consent
Exclusion Criteria:
* Patients with secondary headache (cranioencephalic trauma, cerebral infarction)
* Patients with primary headache other than tension headache
* Suffer heart, liver, and kidney diseases.
* Medications: thiazides
* Pregnant women
* They do not want to participate
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Headache Impact Test, HIT-6
Timeframe: 4 months
Trial details
NCT IDNCT05860062
SponsorHospital de Especialidades, Centro Medico Nacional "La Raza", Instituto Mexicano del Seguro Social