The effect of selenium supplementation on oxidative stress, clinical symptoms and mental health in patients with migraine

The aim of this study is to investigate the effect of selenium supplementation on clinical characteristics, oxidative stress, mental health and quality of life in migraine patients.

Randomized, placebo-controlled, phase 3 on 72 patients. A four-block randomization method will be used.

This study will be conducted on migraine patients referring to the neurology clinic of Al-Zahra Hospital in Isfahan city. At the beginning and end of the 12th week, migraine symptoms, mental health status, and quality of life will be evaluated, and venous blood samples will be taken from the patients. Blinding will be done for patients and researchers.

Inclusion criteria including: migraine diagnosis by a neurologist based on international classification of headache-3, age of 18 to 65 years, having at least two migraine attacks per month, and body mass index of 18.5-30. Exclusion criteria including: pregnancy and lactation, taking antioxidant supplements in the last 3 months, and having a medical history of infectious disorders, cardiovascular diseases, diabetes, liver and kidney diseases, other neurological diseases such as tension headache, epilepsy, Parkinson's and multiple sclerosis.

The patients in the intervention group will receive a 200 microgram selenium tablet (Health Burst) daily for 12 weeks. Control group patients will receive a placebo tablet containing 200 microgram starch (Faculty of Pharmacy, Isfahan University of Medical Sciences) daily for 12 weeks.

Migraine symptoms, patients' quality of life, mental health, oxidative stress status

Due to the strict selection of patients based on the inclusion and exclusion criteria, as well as the reluctance of some patients to participate in the study, the recruitment period has been extended than the period predicted in the previous protocol. Therefore, we considered it necessary to report the change made and correct the estimated date that the recruitment will be ended. Also, more explanations were added in some parts.

Randomization of patients will be done using a four-block randomization method. For this purpose, people were classified into 4 states based on the variables of gender (female, male) and age (18-39, 40-65 years) and people with the same states were randomly assigned to intervention and placebo groups in a 1:1 ratio. 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 and patients will remain blinded to allocation.

This is a double-blind randomized controlled trial. The selenium supplement and placebo are identical in terms of color, smell, shape, and size. They will be packaged in similar boxes and labeled A or B by an independent investigator. Both participants and the outcome assessor will not be informed of the contents of the packages until the end of the study.