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

The purpose of this study is to investigate the effect of vitamin D and probiotic supplements on clinical characteristics, inflammation, oxidative stress, mental health, and quality of life in migraine patients.

Phase 3, randomized, double blind, placebo- controlled, parallel group clinical trial

This study will be conducted on migraine patients referring to Neurology Clinic of Al-Zahra Hospital in Isfahan city. At the beginning and end of the study, blood pressure and anthropometric indicators will be evaluated and a fasting venous blood sample will be collected. The intervention will be performed on patients for 12 weeks and blinding will be done for patients and researchers.

Inclusion criteria are: 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 are: 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

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 weeks. The patients in the control group will recieve for 12 weeks with a probiotic placebo capsule per day containing starch and maltodextrin and a vitamin D placebo pearl containing corn oil.

Clinical characteristics of migraine, inflammation, oxidative stress, mental health, quality of life

Migraine patients will be randomly allocated to intervention and placebo groups in a 1:1 ratio using a four-block randomization method with stratification based on two variables of age (<40, ≥40 years) and sex (female, male). Block randomization will be done using a list of random numbers generated by the website https://www.sealedenvelope.com/simple and by an independent researcher. Investigators, data analysts, and neurologists will remain blinded to treatment allocation.

This is a double-blind randomized controlled clinical trial. The required number of drugs and placebo (identical regarding color, smell, shape, and size) for each patient will be packaged in similar boxes by an independent researcher.