Wednesday, 1 June 2011

Efficacy of vitamin D(3) as add-on therapy in patients with relapsing-remitting multiple sclerosis receiving subcutaneous interferon beta-1a: A Phase II, multicenter, double-blind, randomized, placebo-controlled trial.

Smolders et al. J Neurol Sci. 2011 May 25. [Epub ahead of print]

Small clinical studies of vitamin D supplementation in patients with MS have reported positive immunomodulatory effects, reduced relapse rates and a reduction in the number of gadolinium-enhancing lesions on MRI. However, large randomized clinical trials of vitamin D supplementation in patients with MS are lacking. 

SOLAR (Supplementation of VigantOL(®) oil versus placebo as Add-on in patients with relapsing-remitting multiple sclerosis receiving Rebif(®) treatment) is a 96-week, three-arm, multicenter, double-blind, randomized, placebo-controlled, Phase II trial (NCT01285401). SOLAR will evaluate the efficacy of vitamin D(3) as add-on therapy to subcutaneous interferon beta-1a in patients with RRMS. Recruitment began in February 2011 and is aimed to take place over 1 calendar year due to the potential influence of seasonal differences in 25(OH)D levels.

"At last a properly powered trial to assess add-on vD3 in RRMS. The results should be available in ~3 years time."

CoI: None

2 comments:

  1. What was the prescibed doseage of Vit D3?

    Also, thanks for all your work on this blog - it's so good to know what's going on out there!

    ReplyDelete
  2. Re dose:

    "A total of 348 patients with RRMS and with serum 25(OH)D levels < 150 nmol/L will be randomized (1:1) to receive vitamin D3 or placebo as add-on therapy to IFN beta-1a, 44 μg sc tiw. Patients randomized to vitamin D3 will receive 7000 IU (175 μg) daily for 4 weeks. If treatment with vitamin D is tolerated (as described below), patients will receive 14 000 IU (350 μg) daily for a further 92 weeks; otherwise, patients will continue to receive 7000 IU daily.

    ..............

    Vitamin D3 will be administered as an oral solution (500 μg/mL) each morning during breakfast, as the absorption of a fat-soluble vitamin benefits from the contemporaneous intake of fat (e.g. dropping the daily dose on a piece of buttered bread). sc IFN beta-1a will be administered before going to bed. The exception to this schedule will be during visits to the trial site where vitamin D3, or placebo, will be administered only after the collection of blood samples.
    Serum calcium (< 2.6 mmol/L) levels, as well as the urinary ratio of calcium to creatinine (< 1.0), will be determined before the start of treatment, and at week 4, week 12 and every 12 weeks thereafter. If the urinary ratio of calcium to creatinine is elevated, this measurement will be repeated as soon as possible to confirm the result before any action is taken, as urine calcium levels are highly variable. If any parameter is above the mentioned upper limit of normal for patients receiving 14 000 IU daily, the dose of vitamin D3 may be decreased by 50% (i.e. from 14 000 IU daily to 7000 IU daily) or omitted for 1 month with a re-administration of 50% of the dose thereafter. All patients will continue to receive their dose of IFN beta-1a for the duration of the study."

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