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

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

Clinical trial with placebo control group, with parallel groups, triple blind, randomized, on 58 MS patients, randomization with blocks of 4 using software

The place is the MS Research Center of Sina Hospital in Tehran; on relapsing relapsing MS patients; triple blind; Blinding, randomization and preparation of supplement cans are done by a trained person outside the study so that the participants, researchers and the statistician remain blind until the end of the analyses.

Inclusion criteria: the individual's willingness to participate in the study; definite patients with relapsing-remitting MS based on the 2017 McDonald diagnostic criteria who are on file at Sinai Hospital; age range 18-55 years old; 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. Exclusion criteria: 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.

Intervention group: Magnesium oxide supplement 750 mg in the form of three 250 mg tablets (TDS) for 12 weeks. Control group: placebo supplement, 750 mg of corn starch powder in the form of three 250 mg tablets (TDS) for 12 weeks.

Cognition; depression; anxiety; fatigue; serum levels of magnesium; BDNF; IL-6, and Superoxide Dismutase II

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.

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.

All information can be shared

Beginning of the access period, 6 months after the publication of the results

for everyone

no other conditions

To the email address: abdorrezamoghadasi@gmail.com

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