IRCT201701092639N20
Completed
Phase 2
Evaluation of efficacy of topiramate alone and topiramate with supplement vitamin D3 on monthly frequency, severity, and disability score of headaches in 5-15 year old migraineur children without vitamin D3 deficiency
Shahid Sadoughi University of Medical Sciences, Yazd, Iran0 sites60 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Migraine.
- Sponsor
- Shahid Sadoughi University of Medical Sciences, Yazd, Iran
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •children aged 5\-15 years old; having migraine headache based on International Headache Society Criteria; having one or more headache attack per week; having moderate or severe headache disability; having normal hemoglobin level and mean corpuscular volume (hemoglobin level more than 11\.5g/dl and mean corpuscular volume more than 80 fL); having sufficient vitamin D3 level ( more than 30 ng/mL); have not received vitamin D3 combinations within the past two months; not used any migraine preventive therapy. Exclusion criteria: secondary headaches such as epilepsy or other neurologic disorders; irregular drugs usage; discontinuation of drugs usage for more than one week; allergy to topiramat or vitamin D3; vitamin D3 level more than 80 ng/mL.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified
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