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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230913059422N1

Enrollment

Registered

2023-11-02

Start date

2023-11-01

Completion date

Unknown

Last updated

2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

multiple sclerosis. Multiple sclerosis

Interventions

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, da

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahsa Esfandiary

Oroumia University of Medical Sciences

mahsa.esfandiary.aref@gmail.com+98 21 4423 5833

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026