A randomised, double blind, placebo controlled trial with vitamin D3 as an add on treatment to interferon β-1b in patients with multiple sclerosis.

Posted on January 15, 2013 by Maurice Preter MD

J Neurol Neurosurg Psychiatry. 2012 May;83(5):565-71. doi: 10.1136/jnnp-2011-301876. Epub 2012 Feb 22.

A randomised, double blind, placebo controlled trial with vitamin D3 as an add on treatment to interferon β-1b in patients with multiple sclerosis.

Soilu-Hänninen M, Aivo J, Lindström BM, Elovaara I, Sumelahti ML, Färkkilä M, Tienari P, Atula S, Sarasoja T, Herrala L, Keskinarkaus I, Kruger J, Kallio T, Rocca MA, Filippi M.

Source

Department of Neurology, University of Turku, Turku, Finland. mersoi@utu.fi

Abstract

OBJECTIVES:

To study the safety and efficacy of vitamin D3 as an add on therapy to interferon β-1b (IFNB) in patients with multiple sclerosis (MS).

METHODS:

1 year, double blind, placebo controlled, randomised study in 66 MS patients. The primary outcomes were T2 burden of disease (BOD) on MRI scans, proportion of patients with serum levels of 25-hydroxyvitamin D (25(OH)D) ≥85 nmol/l or intact parathyroid hormone (PTH) ≤20 ng/l, and number of adverse events. Secondary outcomes were number of MRI enhancing T1 lesions and new T2 lesions, annual relapse rate, changes in the Expanded Disability Status Scale score, timed 25 foot walk test and timed 10 foot tandem walk tests.

RESULTS:

Median change in BOD was 287 mm(3) in the placebo group and 83 mm(3) in the vitamin D group (p=0.105). Serum levels of 25(OH)D increased from a mean of 54 (range 19-82) nmol/l to 110 (range 67-163) nmol/l in the vitamin D group. 84% of patients reached a serum 25(OH)D level >85 nmol/l in the vitamin D group and 3% in the placebo group (p<0.0001). Patients in the vitamin D group showed fewer new T2 lesions (p=0.286) and a significantly lower number of T1 enhancing lesions (p=0.004), as well as a tendency to reduced disability accumulation (p=0.071) and to improved timed tandem walk (p=0.076). There were no significant differences in adverse events or in the annual relapse rate.

CONCLUSION:

Vitamin D3 add on treatment to IFNB reduces MRI disease activity in MS.

TRIAL REGISTRATION NUMBER:

EudraCT number 2007-001958-99 and ClinicalTrialsGov number NCT01339676.

Comment in

Treating multiple sclerosis with vitamin D. [J Neurol Neurosurg Psychiatry. 2012]

Multiple sclerosis: Multiple sclerosis therapy–vitamin D under spotlight. [Nat Rev Neurol. 2012]

via A randomised, double blind, pl… [J Neurol Neurosurg Psychiatry. 2012] – PubMed – NCBI.

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A Randomised, Double-Blind, Placebo-Controlled Trial with Vitamin D3 in MS: Subgroup Analysis of Patients with Baseline Disease Activity Despite Interferon Treatment.

Posted on January 15, 2013 by Maurice Preter MD

Mult Scler Int. 2012;2012:802796. doi: 10.1155/2012/802796. Epub 2012 Aug 5.

A Randomised, Double-Blind, Placebo-Controlled Trial with Vitamin D3 in MS: Subgroup Analysis of Patients with Baseline Disease Activity Despite Interferon Treatment.

Aivo J, Lindsröm BM, Soilu-Hänninen M.

Source

Department of Neurology, Turku University Hospital and University of Turku, Kiinamyllynkatu 4-8, 20520 Turku, Finland.

Abstract

We present a subgroup analysis of the first double-blind, placebo-controlled, randomised trial with vitamin D3 in MS. In the overall study population, there were 34 patients in the vitamin D arm and 32 patients in the placebo arm. All the patients were using interferon-β-1b (IFNB) therapy. The subgroup consisted of 15 patients in the vitamin D arm and 15 patients in the placebo arm, who had either at least one relapse during the year preceding the study or enhancing T1 lesions at the baseline MRI scan. We measured the total number of MRI T1 enhancing lesions, the number of new/enlarging T2 lesions and T2 lesion volume (BOD) (mm(3)), EDSS (Expanded Disability Status Scale), annual relapse Rate (ARR), timed 25-foot walk (T25FW), and timed 10-foot tandem walk (TT10W) at baseline and at 12 months in the vitamin D-treated and in the placebo-treated patients. There was a statistically significant reduction in the number of T1 enhancing lesions, a smaller T2 lesion volume growth and less new/enlarging T2 brain MRI lesions in the vitamin D3-treated than in the placebo-treated subgroup patients. The MRI results were slightly more pronounced in the subgroup than in the overall study population.

PMID:

22919492

[PubMed]

PMCID:

PMC3420140

Free PMC Article

via A Randomised, Double-Blind, Placebo-Controlle… [Mult Scler Int. 2012] – PubMed – NCBI.

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Vitamin D status predicts new brain magnetic resonance imaging activity in multiple sclerosis – Mowry – 2012 – Annals of Neurology – Wiley Online Library

Posted on January 15, 2013 by Maurice Preter MD

Vitamin D and New MRI Lesions

>>In univariate models, each 10ng/ml higher vitamin D level was associated with a 15% lower risk of later developing new T2 lesions (IRR, 0.85; 95% CI, 0.76–0.95; p = 0.005). The multivariate results were nearly identical (Table 3). Younger age and cigarette smoking were also associated with increased risk of new T2 lesions. The estimates did not meaningfully change when disease duration, BMI, or HLA-DRB1 status was added to the models, nor did they change if DMT was modeled as a categorical variable or if a person was considered to be on DMT who had received it for at least 3 months of the prior interval. Even after adjusting for baseline vitamin D, each 10ng/ml within-person increase in vitamin D was associated with a much lower risk of developing a new T2 lesion (IRR, 0.67; 95% CI, 0.55–0.83; p < 0.001).<<

via Vitamin D status predicts new brain magnetic resonance imaging activity in multiple sclerosis – Mowry – 2012 – Annals of Neurology – Wiley Online Library.

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Vitamin D status predicts new brain magnetic reso… [Ann Neurol. 2012] – PubMed – NCBI

Posted on January 15, 2013 by Maurice Preter MD
Ann Neurol. 2012 Aug;72(2):234-40. doi: 10.1002/ana.23591.

Vitamin D status predicts new brain magnetic resonance imaging activity in multiple sclerosis.

Mowry EM, Waubant E, McCulloch CE, Okuda DT, Evangelista AA, Lincoln RR, Gourraud PA, Brenneman D, Owen MC, Qualley P, Bucci M, Hauser SL, Pelletier D.

Source

Multiple Sclerosis Center, Department of Neurology, University of California at San Francisco, San Francisco, CA, USA. emowry1@jhmi.edu

Abstract

OBJECTIVE:

We sought to determine whether vitamin D status is associated with developing new T2 lesions or contrast-enhancing lesions on brain magnetic resonance imaging (MRI) in relapsing multiple sclerosis (MS).

METHODS:

EPIC is a 5-year longitudinal MS cohort study at the University of California at San Francisco. Participants had clinical evaluations, brain MRI, and blood draws annually. From the overall cohort, we evaluated patients with clinically isolated syndrome or relapsing-remitting MS at baseline. In univariate and multivariate (adjusted for age, sex, ethnicity, smoking, and MS treatments) repeated measures analyses, annual 25-hydroxyvitamin D levels were evaluated for their association with subsequent new T2-weighted and gadolinium-enhancing T1-weighted lesions on brain MRI, clinical relapses, and disability (Expanded Disability Status Scale [EDSS]).

RESULTS:

A total of 2,362 3T brain MRI scans were acquired from 469 subjects. In multivariate analyses, each 10ng/ml higher 25-hydroxyvitamin D level was associated with a 15% lower risk of a new T2 lesion (incidence rate ratio [IRR], 0.85; 95% confidence interval [CI], 0.76-0.95; p = 0.004) and a 32% lower risk of a gadolinium-enhancing lesion (IRR, 0.68; 95% CI, 0.53-0.87; p = 0.002). Each 10ng/ml higher vitamin D level was associated with lower subsequent disability (-0.047; 95% CI, -0.091 to -0.003; p = 0.037). Higher vitamin D levels were associated with lower, but not statistically significant, relapse risk. Except for the EDSS model, all associations were stronger when the within-person change in vitamin D level was the predictor.

INTERPRETATION:

Vitamin D levels are inversely associated with MS activity on brain MRI. These results provide further support for a randomized trial of vitamin D supplementation.

Copyright © 2012 American Neurological Association.

PMID:
22926855
[PubMed – indexed for MEDLINE]
PMCID:
PMC3430977
[Available on 2013/8/1]

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The influence of nutritional factors on the prognosis of multiple sclerosis : Article : Nature Reviews Neurology

Posted on January 11, 2013 by Maurice Preter MD

 

 

Nature Reviews Neurology 8, 678-689 (December 2012) | doi:10.1038/nrneurol.2012.194

Subject Categories: Neuroimmunology and neuroinflammation | White matter disease

The influence of nutritional factors on the prognosis of multiple sclerosis

Gloria von Geldern & Ellen M. Mowry  About the authors

The effect of nutrition and dietary supplements on the course of multiple sclerosis (MS) is a topic of great interest to both patients and clinicians. In particular, vitamin D status has been shown to influence both the incidence and the course of MS. High vitamin D levels are probably protective against the development of MS, although the efficacy of vitamin D supplementation in slowing progression of MS remains to be established. The influence of polyunsaturated fatty acids (PUFAs) on the development and course of MS has also long been under investigation. Small clinical trials suggest a modest reduction in the severity and duration of relapses in patients with MS receiving PUFA supplements. Other nutritional factors have been evaluated for their effect on MS disease progression, including milk proteins, gluten, probiotics, antioxidants (uric acid, vitamins A, C and E, lipoic acid), polyphenols, Ginkgo biloba extracts and curcumin. However, further studies are needed to evaluate the effects of these dietary components on the relapse rate and progression of MS. This Review gives an overview of the literature on the nutritional factors most commonly implicated as having an effect on MS and discusses the biological rationale that is thought to underlie their influence.

Key points
  • Dietary changes and nutritional supplements are widely used by patients with multiple sclerosis (MS), but reliable evidence of their risks, benefits, and underlying mechanisms is limited
  • In observational studies, low vitamin D levels are associated with a worse course of disease in patients with MS
  • Polyunsaturated fatty acid supplementation and a low-fat diet attenuate MS immune responses in vitro and in animal models, but limited trials have shown no clear benefit in patients with MS
  • Antioxidants, probiotics and vitamin B12 supplementation attenuate MS immune responses in vitro and reduce disease symptoms in animal models, but data from human studies are limited
  • Milk proteins and gluten are thought to worsen the outcomes of patients with MS, but no randomized controlled trials have assessed the effect of dietary restrictions in this setting

 

via The influence of nutritional factors on the prognosis of multiple sclerosis : Article : Nature Reviews Neurology.

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