Effects of adjunct low-dose vitamin D on relapsing-remitting multiple sclerosis progression: Preliminary findings of a randomized, placebo-controlled trial
- Conditions
- relapsing-remitting multiple sclerosis.Multiple sclerosis
- Registration Number
- IRCT201104166202N1
- Lead Sponsor
- Isfahan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
either sex, age between 15 and 60 years, diagnosis of definite RRMS with a MRI, clinical or laboratory, mean (standard deviation) duration equal to 4.3 (2.2) years, range 1-12 years, stable neurological functioning for at least one month prior to the study entry, EDSS score =6, serum 25-hydroxyvitamin D level> 40 ng/ml, willingness to continue current medications for the duration of the study
Exclusion criteria: evidence of substantial abnormalities in neurological, psychiatric, cardiac, endocrinological, hematologic, hepatic, renal, or metabolic functions, use of digitalis, vitamin D supplement, any condition predisposing to hypercalcemia, nephrolithiasis, renal insufficiency, pregnancy as determined by history, physical examination and screening blood tests. secondary-progressive and primary-progressive MS, Women in child-bearing age with no clinically-accepted method of contraception
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Expanded Disability Status Scale (EDSS). Timepoint: 2-months interval, at the baseline and months 2, 4, 6, 8, 10 and 12. Method of measurement: Clinical evaluation by a qualified neurologist.
- Secondary Outcome Measures
Name Time Method umber of relapses. Timepoint: 2-months interval, at the baseline and months 2, 4, 6, 8, 10 and 12. Method of measurement: Clinical evaluation by a qualified neurologist.