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IRCT20220101053582N2 IRCT 2023-06-20 Tehran University of Medical Sciences Investigating the effect of oral magnesium supplementation on cognitive function, fatigue, depression, anxiety of multiple sclerosis patients Investigating the effect of oral magnesium supplementation on cognitive function, fatigue, depression, anxiety and serum levels of magnesium, BDNF, IL-6 and Superoxide Dismutase II in relapsing-remitting multiple sclerosis patients 2023-07-21 anticipated 58 Complete https://irct.ir/trial/70631 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: People participating in the study are selected by easy sampling method. Patients are classified according to age and gender, and each person will be placed in the group receiving magnesium supplement or placebo using random blocks of four with a ratio of 1:1. Blocks of four are randomly designed through the software, such as (ABAB), (BBAB), (AABB), (ABBA), (BAAB). Allocation of A or B to the supplement or placebo group will be done by a person outside of the research implementation, and the researchers will remain blind. Based on the list of prepared random blocks of four, a trained person outside the research team is responsible for randomly allocating patients. After the arrival of each patient, according to the 15 quadruple blocks prepared in the first stage, each patient will be randomly placed in group A or B, and the sample allocation process will be done consecutively until the end of sampling, Blinding description: Patients are classified according to gender and each person will be placed in the group receiving magnesium supplement or placebo using block randomization of four with a ratio of 1:1. This study will be a triple-blind clinical trial, so participants, researchers, neurologists, and data analysts will be unaware that each patient is receiving magnesium supplements or placebo. In this method, one of the letters A or B will be assigned to each group, and for the purpose of blinding, this will be done by the manufacturer of the supplement and placebo. N/A Multiple Sclerosis. Intervention 1: Intervention group: The duration of intervention in this clinical trial will be 12 weeks. Individuals receiving a magnesium supplement will receive 750 mg of magnesium per day in three 250 mg tablets (TDS). Intervention 2: Control group: The duration of intervention in this clinical trial will be 12 weeks. The control group will receive placebo with an equal amount of 750 mg of cornstarch powder daily in the form of three 250 mg dose tablets (TDS). Yes - There is a plan to make this available What will be shared: All information can be shared When: Beginning of the access period, 6 months after the publication of the results To whom: for everyone Conditions: no other conditions Where to obtain: To the email address: abdorrezamoghadasi@gmail.com How to obtain: Send me an email Comments:
public Ali Rezaei Ahvanouei
Tehran University of Medical Sciences, Poursina St., 16th Azar St., Keshavarz Blvd.
Tehran Iran (Islamic Republic of) 1136749986 +98 21 6634 8571 alirezaeeii1375@gmail.com Tehran University of Medical Sciences scientific Abdorreza Naser Moghadasi
Tehran University of Medical Sciences, Poursina St., 16th Azar St., Keshavarz Blvd.
Tehran Iran (Islamic Republic of) 1136749986 +98 21 6634 8571 abdorrezamoghadasi@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) The individual's willingness to participate in the study Definite patients with relapsing-remitting MS based on the 2017 McDonald diagnostic criteria (20) who are on file at Sinai Hospital Age range 18-55 years EDSS less than 5.5 Education above diploma More than one month has passed since the last corticosteroid injection (pulse therapy) More than one month has passed since the last relapse of the disease 18 years 55 years Both Suffering from another neurological disease other than MS Pregnancy or breastfeeding Suffering from chronic gastrointestinal, liver, kidney, heart, respiratory and cancer diseases Having a diet for any reason Suffering from severe psychological disorders such as major depression History of allergy to Magnesium G35 Multiple sclerosis Rehabilitation Placebo Intervention group: The duration of intervention in this clinical trial will be 12 weeks. Individuals receiving a magnesium supplement will receive 750 mg of magnesium per day in three 250 mg tablets (TDS). Control group: The duration of intervention in this clinical trial will be 12 weeks. The control group will receive placebo with an equal amount of 750 mg of cornstarch powder daily in the form of three 250 mg dose tablets (TDS). Cognition. Timepoint: At the beginning of the study and at the end of the 12th week. Method of measurement: MACFIMS test. Anxiety. Timepoint: At the beginning of the study and at the end of the 12th week. Method of measurement: Beck Anxiety Inventory (BAI). Depression. Timepoint: At the beginning of the study and at the end of the 12th week. Method of measurement: Beck Depression Inventory (BDI). Fatigue. Timepoint: and at the end of the 12th week. Method of measurement: Fatigue Severity Scale (FSS) questionnaire. Physical Activity. Timepoint: At the beginning of the study. Method of measurement: International Physical Activity Questionnaire (IPAQ). Magnesium level. Timepoint: At the beginning of the study and at the end of the 12th week. Method of measurement: Blood test. BDNF level. Timepoint: At the beginning of the study and at the end of the 12th week. Method of measurement: Blood test. IL-6 level. Timepoint: At the beginning of the study and at the end of the 12th week. Method of measurement: Blood test. Superoxide Dismutase II activity. Timepoint: At the beginning of the study and at the end of the 12th week. Method of measurement: Calorimetry. Tehran University of Medical Sciences Approved 2023-06-11 Neurorehabilitation Research Institute/MS R.C, Sinai Hospital "Neural Rehabilitation" Neuroscience Research Institute, Imam Khomeini Hospital, Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)