NCT01257958

Brief Summary

Phase 1 study of 19-nor Vitamin D in relapsing-remitting MS. Primary measure is MRI.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Feb 1998

Typical duration for phase_1

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

February 1, 1998

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2000

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2000

Completed
10.5 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 10, 2010

Completed
Last Updated

October 5, 2015

Status Verified

December 1, 2010

Enrollment Period

2 years

First QC Date

December 8, 2010

Last Update Submit

October 1, 2015

Conditions

Keywords

Vitamin D, 19 nor Vitamin D, Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • MRI Measure of new active lesions, observation vs. treatment

Study Arms (1)

19 nor vitamin d

EXPERIMENTAL
Drug: 19 nor vitamin d

Interventions

19 nor vitamin d

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • relapsing remitting MS

You may not qualify if:

  • MRI contraindicated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UW-Madison

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingMultiple Sclerosis

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2010

First Posted

December 10, 2010

Study Start

February 1, 1998

Primary Completion

February 1, 2000

Study Completion

June 1, 2000

Last Updated

October 5, 2015

Record last verified: 2010-12

Locations