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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05860062
Study type Interventional
Source Hospital de Especialidades, Centro Medico Nacional "La Raza", Instituto Mexicano del Seguro Social
Contact Mario A. Mireles Ramírez, Dr.
Phone 3336170060
Email especialidad.cmno@gmail.com
Status Recruiting
Phase N/A
Start date April 18, 2023
Completion date December 20, 2023

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