Safety Trial of High Dose Oral Vitamin D3 With Calcium in Multiple Sclerosis

A Phase I/II Dose-Escalation Trial of Vitamin D3 With Calcium Supplementation in Patients With Multiple Sclerosis

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00644904

Acronym

VitD4MS

Enrollment

Registered

2008-03-27

Start date

2006-07-31

Completion date

2008-02-29

Last updated

2008-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis, Vitamin D, Safety

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTVitamin D3

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Serum calcium	at each dose change

Secondary

Measure	Time frame
EDSS	at screening vs. end of trial
N-telopeptide (bone marker)	—
ALP/AST/ALT	at each dose change
Creatinine/urea	at each dose change
Serum 25(OH)D	at each dose change
Renal ultrasound	at screening, mid-trial and end of trial
Cytokine profile/MMP/lymphocyte response assay	—
Annualized relapse rate	year prior to trial versus year of trial
PTH	at each dose change
EKG	at screening and end of trial

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026