Clinical trial NCT05860062: Vitamin D Supplementation in Episodic and Chronic Tension-type Headache
Official title: Evaluation of Vitamin D Supplementation in Patients With Episodic and Chronic Tension-type Headache.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Tension-Type Headache
Lead sponsor: Hospital de Especialidades, Centro Medico Nacional "La Raza", Instituto Mexicano del Seguro Social
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients selected as the study population will be randomly distributed using a random number table, giving them the number 1, 2 or 3, according to the treatment group they will belong to.
Primary purpose: TREATMENT

Brief 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.

Detailed description: It will be a 4 month study. Each month a package containing treatment will be delivered, which may be conventional medication or tablets with conventional medication added with vitamins.

Eligibility criteria: 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

Primary outcomes:
measure: Headache Impact Test, HIT-6
timeFrame: 4 months
Secondary outcomes:
measure: Depression Beck's Depression II
timeFrame: 4 months
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Hospital de Especialidades
state: Jalisco
Study officials:
affiliation: Hospital de Especialidades
name: Jose J García, Dr.
role: STUDY_DIRECTOR
References: