Vitamin D Supplementation in Episodic and Chronic Tension-type Headache

NCT05860062 | Unknown DMC

• 1 other identifier: R-2023-1301-045
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Tension-Type Headache

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Depression Beck's Depression II

  4 months

Study Arms (3)

calcium+topiramate/amitriptyline

PLACEBO COMPARATOR

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

vitamin D3/calcium+topiramate/amitriptyline,

EXPERIMENTAL

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

vitamin D+topiramate/amitriptyline

ACTIVE COMPARATOR

Patients with prophylactic treatment (amitriptyline, topiramate) + 0.266 mg of calcifediol (15,960 IU of vitamin D)

Dietary Supplement: Vitamin D

Interventions

Vitamin D DIETARY_SUPPLEMENT

Patients with prophylactic treatment (amitriptyline, topiramate) + 0.266 mg of calcifediol (15,960 IU of vitamin D)

Also known as: colecalciferol

vitamin D+topiramate/amitriptyline; vitamin D3/calcium+topiramate/amitriptyline,

Calcium OTHER

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).

calcium+topiramate/amitriptyline; vitamin D3/calcium+topiramate/amitriptyline,

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital de Especialidades, Centro Medico Nacional "La Raza", Instituto Mexicano del Seguro Social: lead

Study Sites (1)

Hospital de Especialidades

Guadalajara, Jalisco, 44340, Mexico

RECRUITING

MeSH Terms

Interventions

Vitamin D; Cholecalciferol; Calcium

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors

Study Officials

• Jose J García, Dr.

  Hospital de Especialidades

  STUDY DIRECTOR

Central Study Contacts

Mario A. Mireles Ramírez, Dr.

CONTACT

3336170060; especialidad.cmno@gmail.com

Martha R Hernández, Dr.

CONTACT

3317208205; mrociohp@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Each month the treatment will be given in equal bottles that will be marked on the label with a color (red, blue, green), the green color corresponding to placebo, red to vitamin D3+calcium and blue to calcium, only the doctors in charge of applying the questionnaires will know the group to which each patient belongs, in this way the double blind is not broken. The placebo will be used to evaluate the effect that produced the feeling of being benefited from a new treatment, the foregoing to avoid bias and have greater reliability of the results, when compared with the gold standard.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Division of health research

Model Details: 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.

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 16, 2023
• Study Start: April 18, 2023
• Primary Completion: September 20, 2023
• Study Completion: December 20, 2023
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)