Chronic Tension-Type HeadacheNCT05860062
Vitamin D Supplementation in Episodic and Chronic Tension-type Headache
A study testing Vitamin D and Calcium in people with Chronic Tension-Type Headache, run by Hospital de Especialidades, Centro Medico Nacional "La Raza", Instituto Mexicano del Seguro Social at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Tension-Type Headache
- What is being tested?
- Vitamin D and Calcium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteMexico
- Study dates
- 18 Apr 2023to 20 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hospital de Especialidades
Guadalajara, Jalisco, 44340
Mario A. Mireles Ramírez, Dr., 3336170060 ext. 31336, especialidad.cmno@gmail.com
About this study
Official title: 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?
Read more
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.
Read the 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.
- Conditions
- Chronic Tension-Type Headache
- Being tested
- Vitamin D, Calcium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
Also called colecalciferol
Patients with prophylactic treatment (amitriptyline, topiramate) + 0.266 mg of calcifediol (15,960 IU of vitamin D)
CalciumOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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) Receives: Dietary Supplement: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (1)
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start18 Apr 2023
- Primary completion20 Sep 2023 (estimated)
- Study completion20 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Tension-Type HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Especialidades, Centro Medico Nacional "La Raza", Instituto Mexicano del Seguro Social
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Mireles, Hospital de Especialidades, Centro Medico Nacional "La Raza", Instituto Mexicano del Seguro Social
- Investigators
- Jose J García, Dr., Study director, Hospital de Especialidades
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860062
- Sponsor's protocol ID
- R-2023-1301-045
- Status last verified
- May 2023
- First submitted
- 24 Apr 2023
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Vitamin D Supplementation in Patients With Episodic and Chronic Tension-type Headache.
- ClinicalTrials.gov ID
- NCT05860062
- Acronym / sponsor ID
- R-2023-1301-045
- Conditions
- Chronic Tension-Type Headache
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospital de Especialidades, Centro Medico Nacional "La Raza", Instituto Mexicano del Seguro SocialUniversity, hospital or other
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- 20 Sep 2023 (estimated)
- Study completion
- 20 Dec 2023 (estimated)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| calcium+topiramate/amitriptyline | Placebo comparator | Other: CalciumPatients 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, | Experimental | Dietary Supplement: Vitamin D, Other: CalciumPatients 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+topiramate/amitriptyline | Active comparator | Dietary Supplement: Vitamin DPatients with prophylactic treatment (amitriptyline, topiramate) + 0.266 mg of calcifediol (15,960 IU of vitamin D) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin DAlso: colecalciferolPatients with prophylactic treatment (amitriptyline, topiramate) + 0.266 mg of calcifediol (15,960 IU of vitamin D) | Dietary supplement | vitamin D+topiramate/amitriptyline, vitamin D3/calcium+topiramate/amitriptyline, |
| Calcium3: 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+topiramate/amitriptyline, vitamin D3/calcium+topiramate/amitriptyline, |
Primary outcome
Headache Impact Test, HIT-6
Time frame: 4 months
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.
1 secondary outcome
Depression Beck's Depression II
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose J García, Dr. study director
Hospital de Especialidades
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D and Calcium in people with Chronic Tension-Type Headache, run by Hospital de Especialidades, Centro Medico Nacional "La Raza", Instituto Mexicano del Seguro Social at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mario A. Mireles Ramírez, Dr. (3336170060 ext. 31336, especialidad.cmno@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache Impact Test, HIT-6 (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.