The effect of probiotic and vitamin D co-supplementation on migraine
Phase 3
Recruiting
- Conditions
- Migraine.Migraine
- Registration Number
- IRCT20121216011763N59
- Lead Sponsor
- Esfahan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
Migraine diagnosis based on international classification of headache
Age of 18 to 65 years
BMI of 18.5 to 29.9 kg/m2
At least two migraine attacks per month
Exclusion Criteria
Taking Vitamin D 3 months before the intervention
Taking probiotic supplements 3 months before the intervention
Taking antibiotic drugs 3 months before the intervention
Suffering from other types of headache
Suffering from neurological disorders, cardiovascular diseases, hypertension, diabetes, malignancies, liver and kidney diseases
Pregnancy or Lactation
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical characteristics of Migraine (frequency, severity, duration of migraine headaches, and headache impact-test-6). Timepoint: At baseline and after 12 weeks. Method of measurement: Headachce Diary and headache impact test-6 questionnaire.;Serum C-reactive Protein. Timepoint: At baseline and after 12 weeks. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kits.;Serum nitric oxide. Timepoint: At baseline and after 12 weeks. Method of measurement: Kiazist biochemical kit.;Oxidant indices (catalase, malondialdehyde, total antioxidant capacity, and total oxidative status). Timepoint: At baseline and after 12 weeks. Method of measurement: Kiazist biochemical kits.;Mental health. Timepoint: At baseline and after 12 weeks. Method of measurement: DASS questionnaire.;Quality of life. Timepoint: At baseline and after 12 weeks. Method of measurement: Migraine –Specific Quality of Life questionnaire.
- Secondary Outcome Measures
Name Time Method