Multiple SclerosisPhase 1/2VitD4MSNCT00644904
Safety Trial of High Dose Oral Vitamin D3 With Calcium in Multiple Sclerosis
A Phase 1/2 study testing Vitamin D3 in people with Multiple Sclerosis, run by University of Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Vitamin D3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2006to Feb 2008
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinically definite MS
- Age 18-55
- EDSS 0-6.5
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Dose-Escalation Trial of Vitamin D3 With Calcium Supplementation in Patients With Multiple Sclerosis
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Vitamin D3
- Keywords
- Multiple Sclerosis, Vitamin D, Safety
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Vitamin D3Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Vitamin D3 |
| Control | Other | Patients are allowed to supplement with up to 4,000 IU per day of Vitamin D3 if desired. Receives: Dietary Supplement: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum calcium
Measured: at each dose change
Secondary outcomes (10)
Serum 25(OH)D
Measured: at each dose change
EDSS
Measured: at screening vs. end of trial
N-telopeptide (bone marker)
ALP/AST/ALT
Measured: at each dose change
Creatinine/urea
Measured: at each dose change
EKG
Measured: at screening and end of trial
Renal ultrasound
Measured: at screening, mid-trial and end of trial
Cytokine profile/MMP/lymphocyte response assay
Annualized relapse rate
Measured: year prior to trial versus year of trial
PTH
Measured: at each dose change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2008 (estimated)
- Study startJul 2006
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Direct MS-Proactive Charity, Multiple Sclerosis Society of Canada
- Investigators
- Jodie M Burton, MD, Principal investigator, St. Michael's Hospital, University of TorontoPaul W O'Connor, MD, MSc, Principal investigator, St. Michael's Hospital, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00644904
- Sponsor's protocol ID
- REB05-147
- Acronym
- VitD4MS
- Status last verified
- Mar 2008
- First submitted
- 24 Mar 2008
- Last updated
- 28 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17823429Kimball 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.
PubMed 21697250Kimball 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.
PubMed 21570386
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Dose-Escalation Trial of Vitamin D3 With Calcium Supplementation in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00644904
- Acronym / sponsor ID
- VitD4MS / REB05-147
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Vitamin D, Safety
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Direct MS-Proactive Charity, Multiple Sclerosis Society of Canada
- Study start
- Jul 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 27 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Dietary Supplement: Vitamin D3Starting 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. |
| Control | Other | Dietary Supplement: Vitamin D3Patients are allowed to supplement with up to 4,000 IU per day of Vitamin D3 if desired. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Clinically definite MS
- Age 18-55
- EDSS 0-6.5
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3 | Dietary supplement | Treatment |
| Vitamin D3 | Dietary supplement | Control |
Primary outcome
Serum calcium
Time frame: at each dose change
10 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2008.
- Background: PubMed 17823429Kimball 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.
- Derived from this study: PubMed 21697250Kimball 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.
- Derived from this study: PubMed 21570386Kimball 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jodie M Burton, MD principal investigator
St. Michael's Hospital, University of Toronto
Paul W O'Connor, MD, MSc principal investigator
St. Michael's Hospital, University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vitamin D3 in people with Multiple Sclerosis, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum calcium (time frame: at each dose change). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00644904, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2008.