Investigating the effect of co-supplementation with alpha-linolenic acid and L-carnitine on inflammatory status, oxidative stress, clinical symptoms, mental health and quality of life in women with migraine

Investigating the effect of co-supplementation with alpha-linolenic acid and L-carnitine on inflammatory status, oxidative stress, clinical symptoms, mental health and quality of life in women with migraine

A controlled, randomized, triple-blind clinical trial with parallel groups, phase 3 on 80 women with migraine. Randomization based on the permuted blocks randomization according to age

The participants will be selected from women migraine patients who refer to the neurologist's office in Isfahan city. At the beginning and end of the study, venous blood samples, anthropometric measurements, questionnaires related to migraine, demographic information and socio-economic status of patients will be measured and recorded.

Inclusion criteria: willingness to participate in the study, diagnosed with migraine by a neurologist, age 20 to 50 years, at least one year has passed after migraine diagnosis. Exclusion criteria: Migraine with aura, suffering from chronic diseases, pregnancy and lactation, taking nutritional supplements in the past 3 months, taking anticoagulants, smoking, and following a special diet.

Intervention: Daily supplement of alpha-linolenic acid (1000 mg of flaxseed oil, one capsule containing 350 mg of alpha-linolenic acid, Barij company) and supplement of L-carnitine (500 mg of L-carnitine, one tablet, Behta Daro company) Control group: Alpha-linolenic acid placebo (parafin oil, one capsul) and L-carnitine placebo (maltodextrin, one tablet) The duration of the intervention: 12 weeks

Clinical symptoms of migraine, oxidative stress and inflammatory status, mental health and quality of life

Changing the block criteria in the randomization of participants

The samples will be randomly placed in one of the four intervention or control groups using permuted block randomization, with blocks of 4. In order to distribute patients into intervention and control groups, first, people are classified into two states in terms of age (less than 35 years/35 years and older). Then, people with the same conditions will be randomly assigned to one of the intervention and control groups. Also, the researcher evaluating the intended outcomes is unaware of the random allocation process and the type of treatment performed.

The study will be conducted as a three-blind study as follows: Medicines and placebo will be provided to all groups in completely identical containers without name labels, prepared in the same color and smell, and coded based on random allocation by the researcher. Therefore, none of the patients were aware of the assigned treatment and will not be informed until the end of the study. Also, the researcher evaluating the intended outcomes is unaware of the random allocation process and the type of treatment performed.