Vitamin D Supplementation in Episodic and Chronic Tension-type Headache
NCT ID: NCT05860062
Last Updated: 2023-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
20 participants
INTERVENTIONAL
2023-04-18
2023-12-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
• 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Randomized, Parallel, Double-blind, Placebo-controlled Study of Vitamin D as Prophylactic Treatment for Migraine
NCT01695460
The Effects of Vitamin D Plus Omega-3 Polyunsaturated Fatty Acids in Patients With Episodic Migraine
NCT05449145
Statin/Vitamin D & Migraine Study
NCT01225263
Influence of a Dietary Supplement as Treatment of Migraine in Children and Adolescents
NCT01010711
An Open-label Study to Evaluate Topiramate Therapy in Migraine Patients, and Its Effects on Subject Responsiveness to Migraine Treatment With Triptans
NCT00261469
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
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.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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).
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).
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).
Vitamin D
Patients with prophylactic treatment (amitriptyline, topiramate) + 0.266 mg of calcifediol (15,960 IU of vitamin D)
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).
vitamin D+topiramate/amitriptyline
Patients with prophylactic treatment (amitriptyline, topiramate) + 0.266 mg of calcifediol (15,960 IU of vitamin D)
Vitamin D
Patients with prophylactic treatment (amitriptyline, topiramate) + 0.266 mg of calcifediol (15,960 IU of vitamin D)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vitamin D
Patients with prophylactic treatment (amitriptyline, topiramate) + 0.266 mg of calcifediol (15,960 IU of vitamin D)
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).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 primary headache other than tension headache
* Suffer heart, liver, and kidney diseases.
* Medications: thiazides
* Pregnant women
* They do not want to participate
18 Years
60 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital de Especialidades, Centro Medico Nacional "La Raza", Instituto Mexicano del Seguro Social
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mario Mireles
Head of the Division of health research
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jose J García, Dr.
Role: STUDY_DIRECTOR
Hospital de Especialidades
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital de Especialidades
Guadalajara, Jalisco, Mexico
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
R-2023-1301-045
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.