Evaluation of the effect of omega-3 supplementation on serum levels of brain-derived neurotrophic factor, high-sensitivity C-reactive protein, and chronic fatigue in patients with multiple sclerosis

Investigating the effect of omega-3 supplementation on serum levels of brain-derived neurotrophic factor, high-sensitivity C-reactive protein, and chronic fatigue in patients with multiple sclerosis

This double-blind, randomized, phase 2 clinical trial will be conducted on 60 patients with multiple sclerosis (MS), including two intervention (n=30) and control (n=30) groups. The method of random allocation is using a table of random numbers.

This double-blind study is conducted at Abadan University of Medical Sciences in collaboration with the Khuzestan MS Association. MS patients who meet the conditions to enter the study are invited to the study by phone. A trained student randomly assigns patients to each of the intervention and control groups. On the first day of the visit, personal information questionnaires, dietary intake of omega-3 fatty acids, chronic fatigue scale, and physical activity are completed. 2 cc of blood is taken from the patient and a supplement or placebo is provided to the patient. At the end of the third month, patients will complete the chronic fatigue questionnaire and IPAQ again, and 2 cc of blood will be taken from the patient after the intervention.

Inclusion criteria: - Age 18-85 years - Diagnosis of MS Exclusion criteria: - Recurrence or treatment with corticosteroids in the last month - Simultaneous treatment with antibiotics and antihypertensive drugs -Pregnancy

1. Intervention group: recipients of omega-3 fatty acid soft capsules with a dose of 1000 mg/d twice a day for 12 weeks. 2. Control group: recipients of oral soft paraffin capsules as a placebo with a dose of 1000 mg/day twice a day for 12 weeks.

Brain-derived neurotrophic factor, and high sensitive C-reactive protein serum levels, Physical activity score, Chronic fatigue scale

Randomization The first step - creating a random sequence (Randomization) In this study, a simple randomization method will be used using a table of random numbers to create a random sequence. To use the table of random numbers, the researcher first predetermines the order of reading the numbers in the table (from above) and then considers even numbers as a default for the intervention group (A) and odd numbers for the control group (B). Then he puts his hand on one of the numbers, moves in one of the predetermined directions, records the numbers, and assigns them to different groups. The second stage - Allocation concealment In this study, opaque sealed and waxed envelopes are used sequentially to hide random allocation (numbered, sealed, opaque envelopes). In this method, after creating a random sequence, based on the research sample size, several envelopes With aluminum wrapping (to obscure the contents of the envelopes), each of the created random sequences is recorded on a card and the cards are placed in the letter envelopes to preserve the random sequence as well. on the surface The outside of the envelopes is numbered in the same order. Finally, the envelopes are sealed and placed inside a box. The envelopes are opened in order and the assigned group of that participant is revealed. An independent medical student (researcher) prepares supplements or supplements with the same color and shape (placebo) as assigned. and puts it in the envelope according to the allocation order. These supplements cannot be distinguished because they contain cans with the same color, shape, and label. The third step - implementing the random allocation process In this study, one of the researchers (faculty member) creates a random sequence, a student who is aware of the study, examines the participants in terms of entry and exit criteria and registers them in the study, and also Another medical student (third party) assigns the participants to groups. The researcher who created the random sequence must be separate from other researchers in the stage of registering the names or allocation of individual participants to reduce possible bias.

This study is conducted in a double-blind manner. In this way, both the participants and the researchers or the outcome assessors are unaware of the allocation of the study groups. The drugs prepared as placebo are completely similar to the omega-3 supplement in terms of color, appearance of the cans and gelatin capsules, smell, and the method of use that is included on the placebo cans so that blinding can be done at the level of the study participants.