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Study aim
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Determining the role of vitamins B12, folic acid and vitamin E in improving MS disease
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Design
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A clinical trial with a control group, parallel groups, double-blind, randomized by blocking, phase 3, on 60 patients, intervention length of 4 months.
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Settings and conduct
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The participants will be selected among MS patients who will come to the neurology clinic of Imam Khomeini Hospital in Urmia. Then, in one meeting, they fill three questionnaires (demographic and disease characteristics, Chalder fatigue (CFQ), quality of life of MS patients (MSQoL-54)) and the neurologist evaluates their EDSS score. Then, in another meeting A blood sample (5 ml) will be taken from each of participant and supplements and placebos will be distributed among them randomly and in a double-blind manner (researcher and participants). After 4 months of taking the pills daily, in the third session, each patient will fill again the mentioned questionnaires and another blood sample will be taken from them. At the end, the data will be analyzed by SPSS 21 software.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Relapsing-remitting Multiple Sclerosis (RRMS) according to McDonald's diagnostic criteria.
EDSS ≤ 6.
Body mass index (BMI) above 17 and below 30.
Age between 18 and 65 years.
Informed consent.
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.
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Intervention groups
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Intervention group: supplement group,
Control group: placebo group
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Main outcome variables
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Severity of disability;
Fatigue rate;
Quality of Life;
Interleukin 17 serum level;
Interferon gamma serum level