Relapsing Remitting Multiple SclerosisPhase 1NCT01257958
Vitamin D Pilot Study in Patients With Multiple Sclerosis
A Phase 1 study testing 19 nor vitamin d in people with Relapsing Remitting Multiple Sclerosis, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Phase 1 study of 19-nor Vitamin D in relapsing-remitting MS. Primary measure is MRI. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- 19 nor vitamin d
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Feb 1998to Jun 2000
- Phase
- Phase 1
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- relapsing remitting MS
Who cannot join
- MRI contraindicated
Trial locations and contacts
1 site in 1 country.
About this study
Phase 1 study of 19-nor Vitamin D in relapsing-remitting MS. Primary measure is MRI.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- 19 nor vitamin d
- Keywords
- Vitamin D, 19 nor Vitamin D, Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
19 nor vitamin dDrug
| Study group | Role | What they receive |
|---|---|---|
| 19 nor vitamin d | Experimental | Not described Receives: Drug: 19 nor vitamin d |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI Measure of new active lesions, observation vs. treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2010 (estimated)
- Study startFeb 1998
- Primary completionFeb 2000
- Study completionJun 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing Remitting Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01257958
- Sponsor's protocol ID
- HSC #97-676-311
- Status last verified
- Dec 2010
- First submitted
- 8 Dec 2010
- Last updated
- 5 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Pilot Study in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01257958
- Acronym / sponsor ID
- HSC #97-676-311
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Keywords
- Vitamin D, 19 nor Vitamin D, Multiple Sclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Feb 1998
- Primary completion
- Feb 2000 (actual)
- Study completion
- Jun 2000 (actual)
- First posted
- 10 Dec 2010 (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.
Phase 1 study of 19-nor Vitamin D in relapsing-remitting MS. Primary measure is MRI.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 19 nor vitamin d | Experimental | Drug: 19 nor vitamin d |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- relapsing remitting MS
Key exclusion criteria (1 listed)
- MRI contraindicated
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 |
|---|---|---|
| 19 nor vitamin d | Drug | 19 nor vitamin d |
Primary outcome
MRI Measure of new active lesions, observation vs. treatment
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 5 Oct 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 19 nor vitamin d in people with Relapsing Remitting Multiple Sclerosis, run by University of Wisconsin, Madison at 1 site in United States.
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 1 inclusion and 1 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 5 Oct 2015. 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 United States. 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 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.
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?
MRI Measure of new active lesions, observation vs. treatment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2015.