NCT05860062

Vitamin D Supplementation in Episodic and Chronic Tension-type Headache

Evaluation of Vitamin D Supplementation in Patients With Episodic and Chronic Tension-type Headache.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Hospital de Especialidades, Centro Medico Nacional "La Raza", Instituto Mexicano del Seguro Social · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Tension-Type Headache

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin D	Patients with prophylactic treatment (amitriptyline, topiramate) + 0.266 mg of calcifediol (15,960 IU of vitamin D)
OTHER	Calcium	3: 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).

Timeline

• Start date: 2023-04-18
• Primary completion: 2023-09-20
• Completion: 2023-12-20
• First posted: 2023-05-16
• Last updated: 2023-05-16

Locations

1 site across 1 country: Mexico