Multiple Sclerosis. Multiple sclerosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Secondary-Progressive MS patients (diagnosed by a neurologist according to expanded disability status scale) Aged between 18-60 years old. Receiving vitamin D3 50000 IU orally per week Consent to participate in the study
Exclusion criteria
Exclusion criteria: Concurrent participation in other clinical trials COVID-19 infection Type 2 diabetes Regular intake of anti-anxiety and anti-depressant drugs The occurrence of MS attack Smoking (at least two cigarettes per day) Adherence to special diets or nutritional supplements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum level of high sensitivity C-Reactive Protein (hs-CRP). Timepoint: At baseline and 8 weeks later. Method of measurement: Chemi Luminescent ImmunoAssays (CLIAs).;Serum Estimated Sedimentation Rate (ESR). Timepoint: At baseline and 8 weeks later. Method of measurement: Westergren method.;Quality of life. Timepoint: At baseline and 8 weeks later. Method of measurement: Multiple Sclerosis Quality of Life (MSQOL-54) 54 items.;Disease activity. Timepoint: At baseline and 8 weeks later. Method of measurement: scoring form of Expanded Disability Status Scale (EDSS). | — |
Secondary
| Measure | Time frame |
|---|---|
| Dietary intakes of vitamins, minerals, and antioxidants. Timepoint: At baseline and 8 weeks later. Method of measurement: N4 software.;Fatigue severity. Timepoint: At baseline and 8 weeks later. Method of measurement: Modified Fatigue Impact Scale 21 items (MFIS) questionnaire.;Pain severity. Timepoint: At baseline and 8 weeks later. Method of measurement: Global Pain Scale (GPS).;Anxiety severity. Timepoint: At baseline and 8 weeks later. Method of measurement: State-Trait Anxiety Inventory (STAI 1 and 2) 20 items.;Gastrointestinal evaluation. Timepoint: At baseline and 8 weeks later. Method of measurement: Gastrointestinal Symptom Rating Scale (GSRS) 15 items.;Body weight. Timepoint: At baseline and 8 weeks later. Method of measurement: SECA digital scale.;Body mass index. Timepoint: At baseline and 8 weeks later. Method of measurement: weight (in kilograms) divided by the square of height (in metres).;Percent of body fat. Timepoint: At baseline and 8 weeks later. Method of measurement: Deurenberg equation.;Triceps Skinfold thickness. Timepoint: At baseline and 8 weeks later. Method of measurement: Skinfold Caliper. | — |
Countries
Iran (Islamic Republic of)
Contacts
Artesh University of Medical Sciences