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IRCT20240604062003N1 IRCT 2024-07-28 Abadan University of Medical Sciences Effect of omega-3 supplementation on myelination, inflammation, and chronic fatigue in patients with multiple sclerosis 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 2024-05-30 anticipated 30 Complete https://irct.ir/trial/77222 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: Dose not have, Randomization description: 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, Blinding description: 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. N/A Multiple Sclerosis. Intervention 1: Intervention group: recipients of omega-3 fatty acid soft capsules with a dose of 1000 mg/d (Zahravai, Tabriz, Iran) twice a day for 12 weeks. Intervention 2: Control group: recipients of oral soft paraffin capsules as a placebo with a dose of 1000 mg/day (Zahravai, Tabriz, Iran) twice a day for 12 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Dr. Mahshid Naghashpour
Vice-Chancellor for Educational and Research, Abadan university of Medical Sciences, Next to Ayatollah Jami International Airport, Airport Ave., Abadan, Iran
Abadan Iran (Islamic Republic of) 6313833177 +98 916 615 7338 mnaghashpour@gmail.com Abadan University of Medical Sciences scientific Mahshid Naghashpour
Dehkadeh Breim, Abadan, Khuzestan, Iran
Abadan Iran (Islamic Republic of) 6313617202 +98 916 615 7338 mnaghashpour@gmail.com Abadan University of Medical Sciences Iran (Islamic Republic of) Age 18-85 years MS diagnosis by a neurologist based on McDonald's criteria (98) Under treatment with MS-modifying drugs with a fixed dose from 6 months before enrolling in the study 18 years 85 years Both Participants in other trials except for the current clinical trial Recurrence or treatment with corticosteroids in the last month- Simultaneous treatment with antibiotics and antihypertensive drugs Other acute or severe diseases except for MS Pregnancy Current or past history of ventricular arrhythmia General health condition that interferes with participation in the study. G35 Multiple sclerosis (of):NOS brain stem cord disseminated generalized Treatment - Drugs Placebo Intervention group: recipients of omega-3 fatty acid soft capsules with a dose of 1000 mg/d (Zahravai, Tabriz, Iran) twice a day for 12 weeks. Control group: recipients of oral soft paraffin capsules as a placebo with a dose of 1000 mg/day (Zahravai, Tabriz, Iran) twice a day for 12 weeks. Mean of Brain-derived neurotrophic factors serum levels. Timepoint: At the beginning of the study (before the start of the intervention) and 12 weeks after the start of taking the omega-3 supplement. Method of measurement: Measurement of BDNF by ELISA: Blood samples will be collected at the beginning and end of the study from all participants between 9:00 and 12:30 to measure total BDNF levels in the serum and clotted for 1 hour at room temperature and then 1 hour at room temperature. It is placed at 4 degrees Celsius. Then, the serum was separated using a centrifuge at 2000 rpm for 10 minutes at 4°C, aliquoted, and stored at -80°C until use in 0.2 ml tube strips (Sarstedt, Multiply® μStripPro). To measure total BDNF serum level, the ELISA kit manufactured by Zelbio, Germany will be used (99). Mean of high sensitive C-reactive protein serum levels. Timepoint: At the beginning of the study (before the start of the intervention) and 12 weeks after the start of taking the omega-3 supplement. Method of measurement: Measurement of hs-CRP: The obtained blood samples will be used to measure the serum inflammatory factor hs-CRP by the Turbidimetric immunoassay (immunoturbidimetry) method. Measure of physical activity. Timepoint: At the beginning of the study (before the start of the intervention) and 12 weeks after the start of taking the omega-3 supplement. Method of measurement: To evaluate physical activity, the International Physical Activity Questionnaire (IPAQ) is used. Mean of chronic fatigue scale score. Timepoint: At the beginning of the study (before the start of the intervention) and 12 weeks after the start of taking the omega-3 supplement. Method of measurement: Assessment of chronic fatigue scale score: A questionnaire consisting of 10 "physical" items, 10 "cognitive" items, and 20 "social" items is used to measure the extent of chronic fatigue of patients in the last 4 weeks. Abadan University of Medical Sciences Approved 2020-04-11 Ethics Committee of Abadan University of Medical Sciences Airport Ave, Abadan university of Medical Sciences, Abadan, Khuzestan, Iran Abadan Khouzestan Iran (Islamic Republic of)