Ignite Creation Date:
2024-05-05 @ 11:52 PM
Last Modification Date:
2024-10-26 @ 10:40 AM
Study NCT ID:
NCT01432704
Status:
COMPLETED
Last Update Posted:
2011-09-13
First Post:
2011-08-16
Brief Title:
Colecalciferol as an Add-on Treatment to Subcutaneously-Administered Interferon-beta-1b for Treatment of Multiple Sclerosis MS
Sponsor:
University of Turku
Organization:
University of Turku
Study Overview
Official Title:
Phase IV Study of Colecalciferol as an Add-on Treatment to Subcutaneously Administered Interferon-beta-1b for Treatment of MS
Status:
COMPLETED
Status Verified Date:
2011-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
100207MS-H
Brief Summary:
This is a one-year multi-centre double blind placebo controlled randomized trial investigating oral vitamin D3 Colecalciferol as an add-on treatment to interferon-beta-1b for Multiple Sclerosis MS Not less than one month after initiation of therapy with interferon beta 1b MS patients will be randomised to once weekly treatment with peroral colecalciferol capsules Dekristol Swiss-Caps Switzerland containing 05 mg of vitamin D3 or to once weekly peroral treatment with matching placebo The hypothesis is that vitamin D suppresses clinical and MRI activity of MS
Detailed Description:
The patients will be examined clinically at baseline and at 6 and 12 months Laboratory assessments will be performed at screening and 1 2 3 6 9 and 12 months after baseline MRI will be performed T1-weighted and T2-weighted at randomization and 12 months thereafter Sample size is 80 patients two groups with 40 patients in each group The primary statistical analyses will be based on the intent-to-treat ITT population which consist of all randomized patients who have started study medication The primary efficacy variable MRI T2 BOD will be analyzed using ANCOVA with MRI T2 BOD at baseline as covariate The incidence with corresponding 95 confidence interval of hypercalcaemia mild moderate and severe laboratory abnormalities dose adjustments and significant adverse events will be calculated The vitamin D status proportion of patients with P-PTH 20 ngl and S-OHD2 85 nmoll at 6 and 12 months will be analyzed using logistic regression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None