Save
Vitamin D supplementation in multiple sclerosis: primary efficacy endpoint and safety of a randomized, controlled, double-blind phase II trial (EVIDIMS)
Author(s): ,
P. Koduah
Affiliations:
NeuroCure Clinical Research Center, Charité - Universitatsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, NeuroCure Cluster of Excellence, Berlin, Germany
,
A.U. Brandt
Affiliations:
NeuroCure Clinical Research Center, Charité - Universitatsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, NeuroCure Cluster of Excellence, Berlin, Germany; Department of Neurology, University of California, Irvine, CA, United States
,
S.K. Piper
Affiliations:
Institute of Biometry and Clinical Epidemiology, Charité - Universitatsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health
,
J. Bellmann-Strobl
Affiliations:
NeuroCure Clinical Research Center, Charité - Universitatsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, NeuroCure Cluster of Excellence, Berlin, Germany; Experimental and Clinical Research Center, Max Delbrück Center for Molecular Medicine & Charité –Universitätsmedizin Berlin, corporate member of Freie Universität Ber
,
J. Wuerfel
Affiliations:
Department of Biomedical Engineering, Medical Imaging Analysis Center, Universitätsspital, Basel, Switzerland
,
F. Paul
Affiliations:
NeuroCure Clinical Research Center, Charité - Universitatsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, NeuroCure Cluster of Excellence, Berlin, Germany; Experimental and Clinical Research Center, Max Delbrück Center for Molecular Medicine & Charité –Universitätsmedizin Berlin, corporate member of Freie Universität Ber
J.-M. Dörr
Affiliations:
NeuroCure Clinical Research Center, Charité - Universitatsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, NeuroCure Cluster of Excellence, Berlin, Germany; Multiple Sclerosis Center, Oberhavel Clinics, Berlin, Germany
ECTRIMS Online Library. Koduah P. Oct 12, 2018; 228159; P1781
Priscilla Koduah
Priscilla Koduah
Login now to access Regular content available to all registered users.

You may also access this content "anytime, anywhere" with the Free MULTILEARNING App for iOS and Android
Abstract
Discussion Forum (0)
Rate & Comment (0)

Abstract: P1781

Type: Poster Sessions

Abstract Category: N/A

Background: Higher serum vitamin D levels are associated with reduced clinical and imaging parameters of disease activity and severity in multiple sclerosis (MS). It is unclear, however, whether vitamin D supplementation positively influences disease activity.
Objective: Our study (NCT01440062) aimed at investigating the superiority and safety of high dose vitamin D supplementation to low dose as an add on therapy to interferon (IFN) β-1b in MS in terms of cranial magnetic resonance imaging (MRI) and clinical parameters.
Methods: We conducted a randomized, controlled, double-blind clinical trial investigating the superiority of 20,400 IU over 400 IU cholecalciferol taken every other day for 18 months in 53 relapsing-remitting (RR)MS patients (high dose arm, n =28; low dose arm, n = 25). Patients were monitored clinically, by cranial MRI, and by laboratory markers. Primary endpoint was the cumulative number of new hyperintense T2 lesions (T2c) after 18 months compared to baseline. T2c was modelled over time using the nonparametric longitudinal data analysis package nparLD including an interaction between time and study arm. Secondary endpoints were: safety, T2 lesion volume, disability progression and annualized relapse rate. We present here results of the per protocol analysis of 38 RR(MS) patients (high dose arm, n =21; low dose arm, n =17). Data are displayed as median and interquartile range [IQR].
Results: Serum levels of 25-OH-Vitamin D in the high dose arm increased from 18 [12; 23]ng/ml to 65 [53; 92]ng/ml at 18 months and in the low dose arm from 16 [10 ;22]ng/ml to 24 [17; 27]ng/ml.
Cumulative new T2c was not significantly different in change over time between study arms (interaction time*arm: p = 0.838). At baseline, median T2 lesion counts were 42 [27; 62] in the high dose arm and 64 [43 ;107] in the low dose arm. At 18 months, median T2c in the high dose arm was 46 [31; 66] and in the low dose arm 70 [43 ;106].
In the low dose arm 34 adverse events were recorded and 44 in the high dose arm. No serious adverse events related to vitamin D were recorded in the study. Further results of the secondary endpoints will be presented at the conference.
Conclusion: High dose supplementation increased serum 25-OH-Vitamin D to sufficient levels with no positive effect on the cumulative number of new T2 lesions. Supplementation with high dose vitamin D (20.400 IU) as an add on therapy to IFN β is safe and tolerable in RRMS patients.
Disclosure: The EVIDIMS trial was partly supported by Bayer Vital GmbH, Germany and the German Research Foundation (DFG Exc 257).
PK is funded by the DFG Excellence grant to FP (DFG exc 257)
AUB is cofounder and shareholder of Motognosis and Nocturne. He is named as inventor on several patent applications regarding MS serum biomarkers, OCT image analysis and perceptive visual computing.
SKP is an independent Biostatistician working at the Institute of Biometry and Clinical Epidemiology of the Charité-Universitätsmedizin Berlin and has nothing to disclose.
JBS received speaking fees and travel grants from Bayer Healthcare, sanofi-aventis/Genzyme, Biogen and Teva Pharmaceuticals, unrelated to the present scientific work.
JW: CEO of MIAC AG in Basel, Switzerland and is on scientific advisory boards of Actelion, Biogen, Genzyme-Sanofi, Novartis, and Roche. His research group received funding from EU (Horizon2020).
FP reports research grants and speaker honoraria from Bayer, Teva, Genzyme, Merck, Novartis, MedImmune and is member of the steering committee of the OCTIMS study (Novartis), all unrelated to this work.
JD Research support by Bayer and Novartis, Honoraria for Lectures and Advisory by Bayer, Biogen, Merck Serono, Sanofi-Genzyme, Novartis, Roche; Travel support by Bayer, Novartis, Merck-Serono, Biogen.

Code of conduct/disclaimer available in General Terms & Conditions
Anonymous User Privacy Preferences

Strictly Necessary Cookies (Always Active)

MULTILEARNING platforms and tools hereinafter referred as “MLG SOFTWARE” are provided to you as pure educational platforms/services requiring cookies to operate. In the case of the MLG SOFTWARE, cookies are essential for the Platform to function properly for the provision of education. If these cookies are disabled, a large subset of the functionality provided by the Platform will either be unavailable or cease to work as expected. The MLG SOFTWARE do not capture non-essential activities such as menu items and listings you click on or pages viewed.


Performance Cookies

Performance cookies are used to analyse how visitors use a website in order to provide a better user experience.



Google Analytics is used for user behavior tracking/reporting. Google Analytics works in parallel and independently from MLG’s features. Google Analytics relies on cookies and these cookies can be used by Google to track users across different platforms/services.


Save Settings