The Effects of Interferon Beta Combined With Vitamin D on Relapsing Re
A One Year Prospective, Randomized, Double Blind Interventional Study to Assess Tolerability, Quality of Life and Immunomodulation With Interferon Beta Combined With Vitamin D in Patients With Relapsing Remitting Multiple Sclerosis
What it found
The trial was stopped early because the treatment was not working.
Reason given: Interim analysis showed that the odds for proving primary hypothesis are low.
What was tested
Treatment tested
- Cholecalciferol
Vitamin D receptor agonist
Compared with
- Cholecalciferol
Vitamin D receptor agonist
What it measured
Main measures
Occurrence and severity of Interferon beta related Flu Like Symptoms and Injection Site Reactions.
One year
Immune responseSafety
Other measures (7)
Expanded Disability Status Scale (EDSS) progression
1 year
Disability progressionRelapse rate
1 year
RelapsesQuality of life
1 year
Quality of life (reported by participants)Change in serum levels of cytokines and proteins involved in MS pathogenesis
12 months
Immune responseImmune cells subsets
6 months
Immune responseNight time Urine levels of 6-sulphatoxy-melatonin
1 year
Percent rise of IL6 and TRAIL levels following IFN-beta injection
3 months
Immune response
Who could take part
Relapsing MS · 18 to 65
Show the full criteria
Inclusion criteria
* Male and female patients with a diagnosis of RRMS according to the McDonald criteria (2005) * At least 18 years of age * Patients are treated with IFN-beta for RRMS. The decision to treat with IFN beta will be independent from this study protocol. * Patients will be either newly diagnosed, who are going to start IFN beta therapy for the first time or RRMS patients who suffer from FLS while being treated with IFN beta. * Insufficient blood levels of 25-hydroxy-vitamin D (below 75nmol/l according to current definitions. * EDSS score up to 7 * Willing and able to give informed consent
Exclusion criteria
* Patients having abnormalities of vitamin D related hormonal system other than low dietary intake or decreased sun exposure will be excluded. Namely, malabsorption [Celiac, Whipple, Inflammatory bowl disease, Intestinal bypass surgery, Short bowel syndrome, Cirrhosis, Nephrotic syndrome, Hyperthyroidism, Renal failure [creatinine clearance of less than 40 ml/min], Rickets, Hypoparathyroidism, Hypercalcemia at baseline, known malignancy, granulomatous disorders (Sarcoidosis, Tuberculosis, Silicosis) and Lymphomas. * Patients who take medications that influence vitamin D metabolism, other than corticosteroids, will be also excluded. Namely, Orlistat, Anticonvulsants [Phenobarbital, Primidone, Phenytoin], Rifampin, Isoniazide, ketoconazole, 5FU and Leucovorin * Patients with conditions with increased susceptibility to hypercalcemia will be excluded too: known arrhythmia or heart disease, treatment with Digitalis, or Hydrochlorothiazide.and those who suffer from nephrolithiasis. * Other Central Nervous System disorders than RRMS * Psychiatric disorders such as psychosis, bipolar disorder or substance abuse * Pregnancy * Contra-indication to treatment with IFN-beta
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The investigators hypothesize that vitamin D supplementation may ameliorate interferon beta-induced flu-like symptoms, owing to reduced release and activity of the cytokines that are in correlation with this adverse event. Vitamin D supplementation may also positively affect injection site reactions due to its immunomodulatory effects. Vitamin D may also augment the therapeutic efficacy of interferon beta among multiple sclerosis (MS) patients. Vitamin D intake may influence melatonin levels of MS patients as they share the same nuclear receptor.
Papers
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History
Started
Oct 2010
Main results due
Apr 2012
Finished
Apr 2012