Vitamin D Supplementation in Episodic and Chronic Tension-type Headache

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Tension-Type Headache
• Intervention / Treatment: Other: Calcium; Dietary supplement: Vitamin D

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mario A. Mireles Ramírez, Dr.; Phone Number: 31336 3336170060; Email: especialidad.cmno@gmail.com
• Study Contact Backup: Name: Martha R Hernández, Dr.; Phone Number: 3317208205; Email: mrociohp@hotmail.com

Study Locations

• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44340
      • Recruiting
      • Hospital de Especialidades
      • Contact: Mario A. Mireles Ramírez, Dr.; Phone Number: 31336 3336170060; Email: especialidad.cmno@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: calcium+topiramate/amitriptyline; 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; 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).
Experimental: vitamin D3/calcium+topiramate/amitriptyline,; 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).	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).; Dietary supplement: Vitamin D; Patients with prophylactic treatment (amitriptyline, topiramate) + 0.266 mg of calcifediol (15,960 IU of vitamin D); Other Names: colecalciferol
Active Comparator: vitamin D+topiramate/amitriptyline; 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); Other Names: colecalciferol

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital de Especialidades, Centro Medico Nacional "La Raza", Instituto Mexicano del Seguro Social
• Investigators: Study Director: Jose J García, Dr., Hospital de Especialidades

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2023
• Primary Completion (Anticipated): September 20, 2023
• Study Completion (Anticipated): December 20, 2023

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: May 7, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 7, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Headache; Tension-Type Headache; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Calcium
• Other Study ID Numbers: R-2023-1301-045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No