Vitamin D likely plays a role in the geography of Multiple Sclerosis (MS), and patients at risk and with MS have relatively low Vitamin D levels compared to their normal counterparts. This trial examines the safety of high dose oral Vitamin D3 titrated up to a maximum of 40,000 IU per day over a 12 month period. Fifty patients matched for MS and non-MS characteristics will be divided into two groups: one group receiving the high dose Vitamin D regimen, and the other restricted to a maximum of 4000 IU per day. The hypothesis is that patients with MS can tolerate seemingly high doses of Vitamin D3 without adverse events and/or calcium-related abnormalities. It is also hypothesized that those receiving the higher doses will demonstrate improved relapse and disability status compared to controls, and that the treatment group will show improved markers of bone health and immune indicators of reduced inflammation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
St. Michael's Hospital
Toronto, Ontario, Canada
Serum calcium
Time frame: at each dose change
Serum 25(OH)D
Time frame: at each dose change
EDSS
Time frame: at screening vs. end of trial
N-telopeptide (bone marker)
ALP/AST/ALT
Time frame: at each dose change
Creatinine/urea
Time frame: at each dose change
EKG
Time frame: at screening and end of trial
Renal ultrasound
Time frame: at screening, mid-trial and end of trial
Cytokine profile/MMP/lymphocyte response assay
Annualized relapse rate
Time frame: year prior to trial versus year of trial
PTH
Time frame: at each dose change
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.