Colecalciferol as an Add-on Treatment to Interferon-beta-1b for Treatm
Colecalciferol as an Add-on Treatment to Subcutaneously Administered Interferon-beta-1b for Treatment of MS
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Cholecalciferol
Vitamin D receptor agonist
Placebo
- Placebo capsules
- Placebo Dekristol SGC 20000
What it measured
Main measures
Measure: the proportion of patients with P-PTH< 20 ng/l and S-OH(D)2 > 85 nmol/l at 6 and 12 months
one year
Other measures (1)
Number of Gadolinium-enhancing lesions on T1 and /or new enlarging lesions on Measure: T2/PD based on MRI done 12 months following randomisation compared with the MRI done at the time of randomisation
one year
MRI lesions
Who could take part
Relapsing MS · 18 to 55
Show the full criteria
Inclusion criteria
* age 18 to 55 years * remitting-relapsing multiple sclerosis according to McDonald criteria who fulfill the reimbursement criteria for interferon-beta and have used interferon-beta-1b for at least one month * EDSS (expanded disability statsu scale) ≤ 5 * no neutralising antibodies to INFB as measured by indirect MxA test * prepared and considered to follow the protocol * using appropriate contraceptive methods (women of childbearing potential) * has given informed consent
Exclusion criteria
* serum calcium >2.6 mmol/L * serum 25(OH)D2 (kalsidiol) > 85 nmol/L * presence of primary hyperparathyroidism (serum intact PTH, parathyroid hormone)>65 ng/L) * pregnancy or unwillingness to use contraception * alcohol or drug abuse * use of glucocorticoid treatment other than intravenous methylprednisolone for treatment of relapses * current use of other immunomodulatory therapy than interferon-beta-1b * known allergy to cholecalciferol or arachis oil (peanuts) * therapy with digitalis, calcitonin or active vitamin D3 analogues during the previous 12 months or multivitamins containing vitamin D during previous two weeks preceding study entry * any condition predisposing to hypercalcaemia (such as any type of cancer) * sarcoidosis * nephrolithiasis or renal insufficiency, serum creatinine above 1.5 times the normal upper reference limit * significant hypertension (Blood Pressure \<180/110 mmHg) * hyperthyroidism, or hypothyroidism in the year before the study began * a history of nephrolithiasis during the previous five years * cardiac insufficiency or significant cardiac dysrhythmia * unstable or advanced ischaemic heart disease * has suffered a major depression
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This is a multi-centre, double blind, randomised, placebo controlled, parallel group, phase 4 pilot study investigating colecalciferol (vitamin D3) as an add-on treatment to subcutaneously administered interferon-beta-1b in relapsing-remitting multiple sclerosis patients.
Papers
Results
Vitamin D supplementation and serum neurofilament light chain in interferon-beta-1b-treated MS patients.Brain Behav · 2020
Results
A randomised, double blind, placebo controlled trial with vitamin D3 as an add on treatment to interferon β-1b in patients with multiple sclerosis.J Neurol Neurosurg Psychiatry · 2012
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History
Started
Mar 2008
Main results due
May 2011
Finished
Jun 2011