Vitamin D Supplementation in Episodic and Chronic Tension-type Headache

Hospital de Especialidades, Centro Medico Nacional "La Raza", Instituto Mexicano del Seguro Social

Status: Enrolling

Conditions: Chronic Tension-Type Headache

Treatments: Other: Calcium; Dietary Supplement: Vitamin D

Study type: Interventional

Funder types: Other

Identifiers

NCT05860062

R-2023-1301-045

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 3 patient groups, including a placebo group

calcium+topiramate/amitriptyline

Placebo Comparator group

Description:

Patients with prophylactic treatment (amitriptyline, topiramate) + and Calcium: 1 Tablet every 24 hours containing: Calcium Carbonate 300 mg + Calcium Lactate Gluconate 2.94 g (500 mg of calcium).

Treatment:

Other: Calcium

vitamin D3/calcium+topiramate/amitriptyline,

Experimental group

Description:

Patients with prophylactic treatment (amitriptyline, topiramate) + Vitamin D and calcium supplementation: 1 Tablet every 24 hours containing: Calcium carbonate 1666.670 mg (600 mg calcium) + Vitamin D3 6.2 mg (400 IU).

Treatment:

Dietary Supplement: Vitamin D

Other: Calcium

vitamin D+topiramate/amitriptyline

Active Comparator group

Description:

Patients with prophylactic treatment (amitriptyline, topiramate) + 0.266 mg of calcifediol (15,960 IU of vitamin D)

Treatment:

Dietary Supplement: Vitamin D