Demyelinating diseases of the central nervous system. Multiple sclerosis
Conditions
Interventions
Intervention 1: Multivitamin-mineral supplementation in intervention group. Intervention 2: Administration of placebo with the same shape and packaging in control group.
Treatment - Other
Placebo
Multivitamin-mineral supplementation in intervention group
Administration of placebo with the same shape and packaging in control group
Sponsors
Sinagene Pharmaceutical Company/ Nano Hayat Daru
Eligibility
Sex/Gender
All
Age
77 Years to 49 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: Patients with definite diagnosis of multiple sclerosis according to McDonald (2010) criteria; Patients with Relapsing Remitting Multiple Sclerosis (RRMS) as the clinical course of disease; Patients must be at range of 18-45 years old; Patients should take every types of interferon for at least 3 months before the study; Patients should not take any supplements from at least 3 months before the study; The fatigue score of patients must be 21-84 based on MFIS questionnaire; Patients should not take any antidepressant SSRI, modafinil, bupropion and Amurel at least 3 months before the study. patients EDSS must be 0-6 Exclusion criteria: Patients with definite diagnosis of severe liver disease, gallstones and pancreatitis, systemic diseases affecting the balance of Th1 / Th2 such as asthma and active viral disease, autoimmune diseases such as SLE and RA,inflammatory bowel disease, type I diabetes; Patients with abnormal result tests of serum ferritin, serum zinc, vitamin D; Patients with malnutrition (BMI less than 19) or obesity (BMI greater than 25); Patients with changes in drugs and diet during the study; ); Patients with known allergic reactions to vitamin supplements; Patients with Pregnancy; Patients with alcohol or drug addiction and Smoking; Patients that forget to use of more than 12 days of supplements (10% of supplementation); Patients with increasing in EDSS more than 1 unit during the study.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IL 17. Timepoint: At first and end of study. Method of measurement: laboratory.;IF gama. Timepoint: At first and end of study. Method of measurement: laboratory.;CRP. Timepoint: At first and end of study. Method of measurement: laboratory.;Fatigue. Timepoint: At first and end of study. Method of measurement: MFIS, ESS Questionnaire.;IL 10. Timepoint: At first and end of study. Method of measurement: laboratory. | — |
Secondary
| Measure | Time frame |
|---|---|
| Depression. Timepoint: At first and end of study. Method of measurement: Beck II questionnare. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Sama Bitarafan
Iranian Center of Neurological Research
Outcome results
None listed