Vitamin D Supplementation in Episodic and Chronic Tension-type Headache

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Tension-Type Headache

Intervention / Treatment
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* Dietary Supplement: Vitamin D
* Other: Calcium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: calcium+topiramate/amitriptyline<br>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). | Other: Calcium<br>* 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).<br>|
| Experimental: vitamin D3/calcium+topiramate/amitriptyline,<br>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). | Dietary Supplement: Vitamin D<br>* Patients with prophylactic treatment (amitriptyline, topiramate) + 0.266 mg of calcifediol (15,960 IU of vitamin D)<br>* Other names: colecalciferol;Other: Calcium<br>* 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).<br>|
| Active Comparator: vitamin D+topiramate/amitriptyline<br>Patients with prophylactic treatment (amitriptyline, topiramate) + 0.266 mg of calcifediol (15,960 IU of vitamin D) | Dietary Supplement: Vitamin D<br>* Patients with prophylactic treatment (amitriptyline, topiramate) + 0.266 mg of calcifediol (15,960 IU of vitamin D)<br>* Other names: colecalciferol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Headache Impact Test, HIT-6 | It consists of 6 questions, assesses the frequency and severity of headaches in general in the last month. Emphasizes the frequency of severe forms of each headache, if it prevents you from doing homework, work or school, if you need to lie down, tiredness, irritability or difficulty concentrating in the last month. The answers will be quantified in: Never (0 points), almost never (5 points), sometimes (10 points), frequently (15 points), always (20 points) and the points of the 6 questions were added. With a total of 48 points or less, it is determined according to the questionnaire that there is no functional limitation, with points between 50 and 60 it is advisable to go to a doctor, between 50 and 54 the impact of disability is slight, from 55 to 68 the impact is moderate and over 60 the impact is severe. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression Beck's Depression II | It is a self-report composed of 21 Likert-type items, used to detect and assess the severity of depression. Each item is answered on a 4-point scale, from 0 to 3, except for items 16 (changes in sleep pattern) and 18 (changes in appetite) which contain 7 categories. If a person chooses several response categories in an item, the category that corresponds to the highest score will be taken. At the end, the points of the 21 items will be added. The minimum and maximum scores on the test are 0 and 63. Cut-off points have been established that allow those evaluated to be classified into one of the following four groups: 0-13, minimal depression; 14-19, mild depression; 20-28, moderate depression; and 29-63, severe depression. | 4 months |