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IRCT2017090133941N20 IRCT 2017-11-16 Kashan University of Medical Sciences Effect of combined omega-3 and vitamin D supplementation in treatment of multiple sclerosis Clinical trial of the effect of combined omega-3 and vitamin D supplementation compared with the placebo on clinical and metabolic status in patients with multiple sclerosis 2017-10-20 anticipated 60 Complete https://irct.ir/trial/26062 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either combined omega-3 and vitamin D supplementation (n = 30) or placebo (n = 30). Randomization will be done by the use of computer-generated random numbers, Blinding description: Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Shahid Beheshti Clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules. 2 Multiple Sclerosis. Intervention 1: Intervention group: 2000 mg omega-3 daily (NutMega, Australia) and 50000 IU vitamin D every 2 weeks (Zahravi, Tabriz, Iran), for 12 weeks orally. Intervention 2: Control group: Placebo capsule (Barij Essence, Kashan, Iran), for 12 weeks orally. 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 Undecided - It is not yet known if there will be a plan to make this available
public Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 81151-87159 +98 31 5546 3378 asemi_z@kaums.ac.ir Kashan University of Medical Sciences scientific Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 81151-87159 +98 31 5546 3378 asemi_z@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Patients with multiple sclerosis Aged 18-55 years Course of disease relapsing–remitting MS (RRMS) EDSS ≤4.5 18 years 55 years Both Pregnancy Lactating during the past 6 month History of nephrolithiasis during the previous5 y No regular menstruation Menopause Unwillingnessto use appropriate contraception G35 Demyelinating disease of the central nervous system Treatment - Drugs Treatment - Drugs Intervention group: 2000 mg omega-3 daily (NutMega, Australia) and 50000 IU vitamin D every 2 weeks (Zahravi, Tabriz, Iran), for 12 weeks orally. Control group: Placebo capsule (Barij Essence, Kashan, Iran), for 12 weeks orally. Expanded Disability Status Scale (EDSS). Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Physical examination by neurologist. Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit. Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Total antioxidant capacity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry. Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit. Insulin resistance. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using HOMA formula. Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. 25-hydroxyvitamin D. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit. Fasting plasma glucose. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. LDL-cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit. Kashan University of Medical Sciences Approved 2017-10-19 Ethics committee of Kashan University of Medical Sciences Ghotbe Ravandi Boulevard, Kashan Kashan Isfehan Iran (Islamic Republic of)