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IRCT20230913059422N1 IRCT 2023-11-02 Oroumia University of Medical Sciences Evaluation of the effect of vitamin B12, folic acid, and vitamin E on Multiple sclerosis amelioration Evaluation of the effect of coincident supplementation of vitamin B12, folic acid, and vitamin E on improvement of clinical signs and serum inflammatory markers in patients with Multiple sclerosis 2023-11-01 anticipated 60 Complete https://irct.ir/trial/72559 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the current study, we will use the blocked randomization method so that the number of samples allocated to each of the studied groups will be equal, and in such a way that it is not clear before the start of the intervention which patient will be in the intervention group and which patient will be in the control group. For this purpose, based on the sample size (60), we will have 6 blocks (including 3 participants in the intervention group and 3 participants in the control group). Then all possibilities of AAABBB will be considered. The number of blocks will be 10, which will be listed randomly by balloting. For concealment, a code will be randomly allocated to each patient and it will remain hidden that which code is allocated to each patient.The generated codes will be randomly listed, then based on the list of codes, they will be assigned to the intervention group (A) or control group (B) through the mentioned blocking. All the steps of randomization will be done under the supervision of an epidemiologist consultant. Random Allocation version 1.0.0 software will be used for randomization, which is capable of both simple randomization and generating a random sequence using the blocking method, Blinding description: In this study, in order to blind the participants, in coordination with pharmaceutical company, a placebo similar to the supplement under the study will be prepared which will be completely identical in shape and will be used with the same usage method and will be released to the individuals based on the code. The researcher also will not know which code is dedicated to each group until the last stage. In the stage of statistical analysis, people will be entered based on the code, and finally, the codes will be revealed at the end. 3 multiple sclerosis. Intervention 1: Intervention group: Vitamin B12 (1000 micrograms), sublingual tablet, daily intake for 4 months, produced by Amin Pharmaceutical Company / Folic acid (1000 micrograms), oral tablet, daily intake for 4 months, with food, produced by Iran Daru Pharmaceutical Company / Vitamin E (200 IU), softgel, daily intake for 4 months, produced by Amin Pharmaceutical Company. Intervention 2: Control group: vitamin B12 (1000 micrograms) placebo, sublingual tablet, daily intake for 4 months, produced by Amin Pharmaceutical Company/folic acid (1000 micrograms) placebo, oral tablet, daily intake for 4 months, consumption with food, produced by Pharmaceutical Company Iran Daru/Vitamin E (200 IU) placebo, softgel, daily intake for 4 months, consumption with food, produced by Amin Pharmaceutical Company. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access round starts from March 2025 To whom: Researchers working in academic and scientific institutions and also people who are engaged in industry Conditions: For therapeutic and research purposes, it will be accessible to the therapists and researchers of creditable and legal centers Where to obtain: Send request to mahsa.esfandiary.aref@gmail.com How to obtain: After sending request to mahsa.esfandiary.aref@gmail.com, the answer will be given within one month. Comments:
public Mahsa Esfandiary
1st Floor, No. 9, Sajjadi Alley, 1st Aramkan St., Jalal Al Ahmad Hwy.
Tehran Iran (Islamic Republic of) 1463634881 +98 21 4423 5833 mahsa.esfandiary.aref@gmail.com Oroumia University of Medical Sciences scientific Mahsa Esfandiary
1st Foor, No. 9, Sajjady Alley, 1st Armakan St., Jalal Al Ahmad HWY., Tehran City
Tehran Iran (Islamic Republic of) 1463634881 +98 21 4423 5833 mahsa.esfandiary.aref@gmail.com Oroumia University of Medical Sciences Iran (Islamic Republic of) Relapsing-remitting Multiple Sclerosis (RRMS) according to McDonald's diagnostic criteria EDSS score equal to 6 or less (EDSS ≤ 6) Body mass index (BMI) above 17 and below 30 Age between 18 and 65 years Informed consent 18 years 65 years Both Atrophy of the optic nerve (Leber's disease) Consumption of aminoglycosides, chloramphenicol, colchicine, continuous potassium release products, aminosalicylic acid and its solutions, anticonvulsant drugs and alcohol Taking folate, vitamin B12 and vitamin E supplements up to one year before the start of the study Thyroid disorders IBD IBS G35 Multiple sclerosis Treatment - Drugs Placebo Intervention group: Vitamin B12 (1000 micrograms), sublingual tablet, daily intake for 4 months, produced by Amin Pharmaceutical Company / Folic acid (1000 micrograms), oral tablet, daily intake for 4 months, with food, produced by Iran Daru Pharmaceutical Company / Vitamin E (200 IU), softgel, daily intake for 4 months, produced by Amin Pharmaceutical Company Control group: vitamin B12 (1000 micrograms) placebo, sublingual tablet, daily intake for 4 months, produced by Amin Pharmaceutical Company/folic acid (1000 micrograms) placebo, oral tablet, daily intake for 4 months, consumption with food, produced by Pharmaceutical Company Iran Daru/Vitamin E (200 IU) placebo, softgel, daily intake for 4 months, consumption with food, produced by Amin Pharmaceutical Company Severity of disability (Expanded Disability Status Scale). Timepoint: At the beginning of the study (before the start of the intervention) and 4 months after the start of taking the supplements. Method of measurement: Examination of a neurologist. Fatigue rate. Timepoint: At the beginning of the study (before the start of the intervention) and 4 months after the start of taking the supplements. Method of measurement: Chalder fatigue questionnaire. Quality of life. Timepoint: At the beginning of the study (before the start of the intervention) and 4 months after the start of taking the supplements. Method of measurement: Multiple Sclerosis Quality of Life-54 questionnaire. Interleukin 17 serum level. Timepoint: At the beginning of the study (before the start of the intervention) and 4 months after the start of taking the supplements. Method of measurement: Blood sampling. Serum level of interferon gamma. Timepoint: At the beginning of the study (before the start of the intervention) and 4 months after the start of taking the supplements. Method of measurement: Blood sampling. Calorie intake in the diet. Timepoint: Before the start of the intervention, after the end of the intervention. Method of measurement: 24-hour food reminder. Intake of macronutrients in the diet. Timepoint: Before the start of the intervention, after the end of the intervention. Method of measurement: 24-hour food reminder. Vitamin B12 intake in the diet. Timepoint: Before the start of the intervention, after the end of the intervention. Method of measurement: 24-hour food reminder. Folic acid intake in the diet. Timepoint: Before the start of the intervention, after the end of the intervention. Method of measurement: 24-hour food reminder. Vitamin E intake in the diet. Timepoint: Before the start of the intervention, after the end of the intervention. Method of measurement: 24-hour food reminder. Oroumia University of Medical Sciences Approved 2023-06-24 Ethics committee of Urmia University of Medical Sciences Urmia University of Medical Sciences, 11th Km of Nazloo Rd. Urmia West Azarbaijan Iran (Islamic Republic of)