The effect of probiotic and vitamin D co-supplementation on migraine

Evaluating the effect of probiotic and vitamin D co-supplementation on clinical indices, inflammation, oxidative stress, mental health, and quality of life in patients with migraine

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20121216011763N59

Enrollment

Registered

2023-05-04

Start date

2023-05-22

Completion date

Unknown

Last updated

2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine. Migraine

Interventions

Intervention 1: The patients in the intervention group will recieve for 12 weeks with a probiotic capsule per day (Farabiotic Company) and a vitamin D pearl (50000 IU) (Zahrava Company) every two week

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Gholamreza Askari

Esfahan University of Medical Sciences

askari@mui.ac.ir+98 31 3792 3060

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026