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IRCT20240702062304N1 IRCT 2024-07-07 Abadan University of Medical Sciences Effect of Omega-3 supplementation in patients with multiple sclerosis MS Effect of Omega-3 supplementation on serum level of interferon-gamma in patients with multiple sclerosis 2024-07-21 anticipated 60 Complete https://irct.ir/trial/77714 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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 description: 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. 3 Multiple sclerosis. Intervention 1: Intervention group: They will receive a dose of 1000 mg of omega-3 for three months, two omega-3 softgels daily. Intervention 2: Control group: will receive a dose of 1000 mg of omega-3 placebo for three months, two omega-3 placebo softgels daily. No - There is not a plan to make this available Justification or reason for not sharing IPD is 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.
public Sahar Golabi
Educational, research and technology deputy of Abadan University of Medical Sciences, in front of Ayatollah Jami Airport, Abadan, Iran
Abadan Iran (Islamic Republic of) 6313833177 +98 61 5326 7800 sgolabister@gmail.com Abadan University of Medical Sciences scientific Sahar Golabi
Educational, research and technology deputy of Abadan University of Medical Sciences, in front of Ayatollah Jami Airport, Abadan, Iran
Abadan Iran (Islamic Republic of) 6313833177 +98 61 5326 7800 sgolabister@gmail.com Abadan University of Medical Sciences Iran (Islamic Republic of) Patients with MS (diagnosis of MS based on McDonald's criteria) Age 18 to 85 years All types of MS (relapsing-remitting and progressive types) Treated with MS course-modifying drugs at a fixed dose for 6 months before study enrollment 18 years 85 years Both Participants in other trials except the present clinical trial Recurrence or treatment with corticosteroids in the last month Simultaneous treatment with antibiotics and antihypertensive drugs Other acute or severe diseases except MS Pregnancy Current or past history of ventricular arrhythmia A general health condition that interferes with participation in the study G35 Multiple sclerosis Treatment - Drugs Placebo Intervention group: They will receive a dose of 1000 mg of omega-3 for three months, two omega-3 softgels daily. Control group: will receive a dose of 1000 mg of omega-3 placebo for three months, two omega-3 placebo softgels daily. Serum interferon-gamma level. Timepoint: Interferon gamma serum levels will be measured before and after the period of use (3 months) in the drug and placebo groups. Method of measurement: Using a specialized kit for measuring interferon gamma by ELISA method. Serum interferon- gamma level. Timepoint: Before the start of the intervention - day 1 of the study and after the end of the intervention - day 90 of the study. Method of measurement: Using a specialized kit for measuring interferon gamma factor in human serum by ELISA method. Abadan University of Medical Sciences Approved 2020-04-11 Ethics committee of Abadan University of Medical sciences Educational, research and technology deputy of Abadan University of Medical Sciences, in front of Ayatollah Jami Airport, Abadan, Iran Abadan Khouzestan Iran (Islamic Republic of)