Effect of Omega-3 supplementation on serum level of interferon-gamma in patients with multiple sclerosis

Comparison of the mean total interferon gamma serum levels between MS patients treated with omega-3 supplements and placebo before and after the intervention by sex, age, BMI, and disease duration

Patients covered by the MS Association of Khuzestan province, Abadan, and Ahvaz branches are included in the study. Patients' sera are collected to measure the level of gamma interferon. The study is conducted as a randomized double-blind clinical trial with parallel groups of 60 patients.

Multiple sclerosis is an autoimmune and inflammatory disease. Omega-3 fatty acids are a family of unsaturated fatty acids that are essential for regulating the activities of the human body. Several studies have shown the neuroprotective role of omega-3 fatty acids in various conditions, including neurodegenerative diseases. This study will be conducted at Abadan University of Medical Sciences in collaboration with the Khuzestan MS Association. Blinding will be two-way.

Inclusion criteria: Age 18-85 years, MS diagnosis, All types of MS ) - Being treated with MS course-modifying drugs Exclusion criteria: Participants in other trials, Recurrence, or treatment with corticosteroids in the last month, Simultaneous treatment with antibiotics and antihypertensive drugs, Other acute or severe diseases, Pregnancy, ventricular arrhythmia, General health condition that interferes with participation in the study

Intervention group: Omega-3 fatty acid soft capsules with a dose of 1000 mg per day are received twice a day after lunch and dinner for 12 weeks. Control group: Oral soft paraffin capsule as a placebo with a dose of 1000 mg twice a day after lunch and dinner for 12 weeks.

The outcome of this study is the serum interferon-gamma level.

The random allocation of the participants to two intervention and control groups will be done using random allocation software and random numbers generated by the computer.The sequence of random allocation, registration of patients, and their allocation in intervention and control groups will be done by trained students. After meeting the inclusion criteria, participants are randomized to receive omega-3 fatty acid supplementation or placebo by a trained student who distributes omega-3 fatty acid capsules or placebo according to a computer-generated randomization list. Randomization and allocation will be concealed from investigators and patients until the final analysis is completed. To control the effect of indoctrination following the consumption of capsules, a placebo will also be used in the control group.

Blinding will be two-way. In this way, the participants and the researcher will not know about the allocation group. Blinding will be done and followed up during 3 months by asking the participants and all the research staff involved in prescribing and measuring the results regarding being aware of the group allocation.

Due to the personal nature of the disease and in order to protect the privacy of the patients as much as possible, there is no plan for publication.