An interventional study of Vitamin D and Calcium in Chronic Tension-Type Headache, sponsored by Hospital de Especialidades, Centro Medico Nacional "La Raza", Instituto Mexicano del Seguro Social. Recruiting at 1 site in Mexico. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-16.
Sponsored by Hospital de Especialidades, Centro Medico Nacional "La Raza", Instituto Mexicano del Seguro Social · Not applicable, Interventional, and Treatment
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:
Patients will have the next selection criteria:
The population will be randomly divided into the following 3 treatment groups:
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.
144 studies on the registry are indexed under Tension-Type Headache; 41 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 109 interventional studies indexed under Tension-Type Headache.
Browse Tension-Type Headache studies →Hospital de Especialidades, Centro Medico Nacional "La Raza", Instituto Mexicano del Seguro Social is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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 · Other: Calcium
Patients with prophylactic treatment (amitriptyline, topiramate) + 0.266 mg of calcifediol (15,960 IU of vitamin D)
Dietary Supplement: Vitamin D
Patients with prophylactic treatment (amitriptyline, topiramate) + 0.266 mg of calcifediol (15,960 IU of vitamin D)
Also known as: colecalciferol
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).
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.
Time frame: 4 months
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.
Time frame: 4 months
Plan to share: No
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Hospital de Especialidades, Centro Medico Nacional "La Raza", Instituto Mexicano del Seguro Social