Colecalciferol as an Add-on Treatment to Subcutaneously-Administered I
Phase IV Study of Colecalciferol as an Add-on Treatment to Subcutaneously Administered Interferon-beta-1b for Treatment of MS
What it found
The main measure did not show a significant benefit.
“Median change in BOD was 287 mm(3) in the placebo group and 83 mm(3) in the vitamin D group (p=0.105).”Read by software from the paper's abstract
1 year
| Group | n | Value |
|---|---|---|
| Placebo | 287 mm(3) | |
| Vitamin D | 83 mm(3) |
p = 0.105
Total participants: 66
Read by software from the paper's abstract
This trial finished 15 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Cholecalciferol
Vitamin D receptor agonist
What it measured
Main measures
To evaluate the safety and tolerability of add-on -treatment with colecalciferol of MS patients treated with interferon beta-1b and
one year
Immune responseSafetyTo estimate the effect of interferon-beta-1b with an add-on of colecalciferol versus interferon-beta-1b with an add-on of placebo on MRI T2 BOD at 12 months in comparison with MRI T2 BOD at baseline
12 months
MRI lesionsImmune response
Other measures (1)
Number of Gadolinium-enhancing lesions on T1 and /or new enlarging lesions on T2/PD based on MRI done 12 months following randomisation compared with the MRI done at the time of randomisation
12 Months
MRI lesions
Who could take part
Relapsing MS · 18 to 50 · EDSS 0 to 5
Show the full criteria
Inclusion criteria
* RRMS EDSS 0-5 * Betaferon used for at lest one month with positive MxA-response
Exclusion criteria
* hypercalcaemia * kidney stones * uncontrolled hypertension * hypothyreosis * peanut allergy * severe depression * sarcoidosis * use of other IMD than interferon-beta
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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 0.5 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.
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History
- Result signal changed from Results published to Finished, no results found
- Result signal changed from Finished, no results found to Results published
- In scope changed from false to true
- In scope changed from true to false
Started
Mar 2008
Main results due
May 2011
Finished
Aug 2011