NCT00644904

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P75+ for phase_1 multiple-sclerosis

Timeline
Completed

Started Jul 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 27, 2008

Completed
Last Updated

March 28, 2008

Status Verified

March 1, 2008

Enrollment Period

1.6 years

First QC Date

March 24, 2008

Last Update Submit

March 27, 2008

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisVitamin DSafety

Outcome Measures

Primary Outcomes (1)

  • Serum calcium

    at each dose change

Secondary Outcomes (10)

  • Serum 25(OH)D

    at each dose change

  • EDSS

    at screening vs. end of trial

  • N-telopeptide (bone marker)

  • ALP/AST/ALT

    at each dose change

  • Creatinine/urea

    at each dose change

  • +5 more secondary outcomes

Study Arms (2)

Treatment

EXPERIMENTAL

Starting dose of 4,000 IU per day of Vitamin D3 titrating up to a dose of 40,000 IU per day of Vitamin D3 by month six. In the second six-month part of the trial, patients titrate back down to 4,000 IU per day of Vitamin D3 and then discontinue it completely at the end of the 12 month trial period.

Dietary Supplement: Vitamin D3

Control

OTHER

Patients are allowed to supplement with up to 4,000 IU per day of Vitamin D3 if desired.

Dietary Supplement: Vitamin D3

Interventions

Vitamin D3DIETARY_SUPPLEMENT
Treatment

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Clinically definite MS
  • Age 18-55
  • EDSS 0-6.5

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (3)

  • 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.

    PMID: 17823429BACKGROUND

  • Kimball S, Vieth R, Dosch HM, Bar-Or A, Cheung R, Gagne D, O'Connor P, D'Souza C, Ursell M, Burton JM. Cholecalciferol plus calcium suppresses abnormal PBMC reactivity in patients with multiple sclerosis. J Clin Endocrinol Metab. 2011 Sep;96(9):2826-34. doi: 10.1210/jc.2011-0325. Epub 2011 Jun 22.

    PMID: 21697250DERIVED

  • 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.

    PMID: 21570386DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Jodie M Burton, MD

    St. Michael's Hospital, University of Toronto

    PRINCIPAL INVESTIGATOR

  • Paul W O'Connor, MD, MSc

    St. Michael's Hospital, University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 24, 2008

First Posted

March 27, 2008

Study Start

July 1, 2006

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

March 28, 2008

Record last verified: 2008-03

Locations

CA(1)