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NCT05860062
Vitamin D Supplementation in Episodic and Chronic Tension-type Headache
NA trial testing Vitamin D in Chronic Tension-Type Headache in 20 participants. Status unknown.
20 September 2023
Quick facts
| Lead sponsor | Hospital de Especialidades, Centro Medico Nacional "La Raza", Instituto Mexicano del Seguro Social |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 18 April 2023 |
| Primary completion | 20 September 2023 |
| Estimated completion | 20 December 2023 |
| Sites | 1 location across Mexico |
Drugs / interventions tested
- Vitamin D
- Calcium (CALCIUM) — full drug profile →
Conditions studied
- Chronic Tension-Type Headache — all drugs for Chronic Tension-Type Headache →
Sponsor
Hospital de Especialidades, Centro Medico Nacional "La Raza", Instituto Mexicano del Seguro Social
Who can join
Adults 18 to 60, any sex, with Chronic Tension-Type Headache. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Hallmarks of primary headache: part 2- Tension-type headache.
Pan LH, Ling YH, Wang SJ, Al-Hassany L, et al · · 2025 · cited 17× · PMID 40676501 · DOI 10.1186/s10194-025-02098-w
Verify or expand the search:
- PubMed search for NCT05860062
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Other Hospital de Especialidades, Centro Medico Nacional "La Raza", Instituto Mexicano del Seguro Social trials
Trials by the same sponsor.
- NCT05579119 — SITAgliptin Plus GLARgine to Glycemic Control in the Hospital Setting (SITAGLAR-H) · Phase 4 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05860062 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hospital de Especialidades, Centro Medico Nacional "La Raza", Instituto Mexicano del Seguro Social
- Last refreshed: 16 May 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05860062.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing