Impact of multivitamin on fatigue and inflammatory cytokines in multiple sclerosis

Not Applicable

• Conditions: Demyelinating diseases of the central nervous system.; Multiple sclerosis

• Registration Number: IRCT2016022026658N1
• Lead Sponsor: Sinagene Pharmaceutical Company/ Nano Hayat Daru

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 100

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

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Depression. Timepoint: At first and end of study. Method of measurement: Beck II questionnare.