Safety Trial of High Dose Oral Vitamin D3 With Calcium in Multiple Scl
A Phase I/II Dose-Escalation Trial of Vitamin D3 With Calcium Supplementation in Patients With Multiple Sclerosis
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Cholecalciferol
Vitamin D receptor agonist
What it measured
Main measures
Serum calcium
at each dose change
Other measures (10)
Serum 25(OH)D
at each dose change
EDSS
at screening vs. end of trial
Disability progressionN-telopeptide (bone marker)
ALP/AST/ALT
at each dose change
Creatinine/urea
at each dose change
EKG
at screening and end of trial
Renal ultrasound
at screening, mid-trial and end of trial
Cytokine profile/MMP/lymphocyte response assay
Immune responseAnnualized relapse rate
year prior to trial versus year of trial
RelapsesPTH
at each dose change
Who could take part
MS (type not specified) · 18 to 55 · EDSS 0 to 6.5
Show the full criteria
Inclusion criteria
* Clinically definite MS * Age 18-55 * EDSS 0-6.5
Exclusion criteria
* EDSS => 7.0 * Current Vitamin D3 use >4000 IU/d * Baseline (25(OH)D) level \<20 mmol/L (frank deficiency) and >150 mmol/L * Pregnancy or inability/unwillingness to use contraception * History of cardiac arrhythmia * History of renal disease and nephrolithiasis * History of granulomatous disease or lymphoma * Relapse activity or steroid use in the past 60 days
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Cholecalciferol plus calcium suppresses abnormal PBMC reactivity in patients with multiple sclerosis.J Clin Endocrinol Metab · 2011
Results
A phase I/II dose-escalation trial of vitamin D3 and calcium in multiple sclerosis.Neurology · 2010
Results
Kimball SM, Burton JM, O'Connor PG, Vieth R. Urinary calcium response to high dose vitamin D3 with calcium supplementation in patients with multiple sclerosis. Clin Biochem. 2011 Jul;44(10-11):930-2. doi: 10.1016/j.clinbiochem.2011.04.017. Epub 2011 May 5.Background
Kimball SM, Ursell MR, O'Connor P, Vieth R. Safety of vitamin D3 in adults with multiple sclerosis. Am J Clin Nutr. 2007 Sep;86(3):645-51. doi: 10.1093/ajcn/86.3.645.
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History
Started
Jul 2006
Main results due
Feb 2008
Finished
Feb 2008