High-dose vitamin D supplementation in multiple sclerosis - results from the randomized EVIDIMS (efficacy of vitamin D supplementation in multiple sclerosis) trial

被引：38

作者：

Doerr, Jan ^{[2
,3
,4
,5
]}

Baecker-Koduah, Priscilla ^{[2
,3
,4
,5
]}

Wernecke, Klaus-Dieter ^{[2
,3
,6
,7
]}

Becker, Elke ^{[8
]}

Hoffmann, Frank ^{[9
]}

Faiss, Juergen ^{[10
]}

Brockmeier, Bernd ^{[11
]}

Hoffmann, Olaf ^{[2
,3
,12
,13
]}

Anvari, Kerstin ^{[14
]}

Wuerfel, Jens ^{[2
,3
,12
,15
]}

Piper, Sophie K. ^{[2
,3
,7
,16
]}

Bellmann-Strobl, Judith ^{[2
,3
,5
,12
,17
,18
]}

Brandt, Alexander U. ^{[1
,2
,3
,12
,18
,19
]}

Paul, Friedemann ^{[1
,2
,3
,5
,12
,17
,18
]}

机构：

[1] Oberhavel Clin, MS Clin, Dept Neurol, Hennigsdorf, Germany

[2] Charite Univ Med Berlin, Charitepl 1, D-10117 Berlin, Germany

[3] Humboldt Univ, Freie Univ Berlin, Berlin, Germany

[4] Max Delbrueck Ctr Mol Med, Berlin Inst Hlth, NeuroCure Clin Res Ctr, Berlin, Germany

[5] Berlin Inst Hlth, Expt & Clin Res Ctr, Berlin, Germany

[6] SOSTANA GmbH, Konnern, Germany

[7] Berlin Inst Hlth, Inst Biometry & Clin Epidemiol, Berlin, Germany

[8] Neurol Facharztzentrum Berlin, Berlin, Germany

[9] Krankenhaus Martha Maria Halle Doelau, Dept Neurol, Halle, Germany

[10] Asklepios Kliniken Teupitz & Lubben, Dept Neurol, Teupitz, Germany

[11] Neurol Mexikopl, Berlin, Germany

[12] Berlin Inst Hlth, NeuroCure Clin Res Ctr, Berlin, Germany

[13] Alexianer St Josefs Krankenhaus, Dept Neurol, Potsdam, Germany

[14] Neurol Praxis Anvari, Berlin, Germany

[15] Univ Basel, MIAC AG & Qbig, Dept Biomed Engn, Basel, Switzerland

[16] Berlin Inst Hlth BIH, Anna Louisa Karsch 2, Berlin, Germany

[17] Max Delbrueck Ctr Mol Med, Berlin, Germany

[18] Berlin Inst Hlth, Dept Neurol, Berlin, Germany

[19] Univ Calif Berkeley, Dept Neurol, Berkeley, CA 94720 USA

来源：

MULTIPLE SCLEROSIS JOURNAL-EXPERIMENTAL TRANSLATIONAL AND CLINICAL | 2020年 / 6卷 / 01期

关键词：

Multiple sclerosis; clinical trial; vitamin D; efficacy; treatment; supplementation;

D O I：

10.1177/2055217320903474

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

Background Epidemiological, preclinical, and non-interventional studies link vitamin D (VD) serum levels and disease activity in multiple sclerosis (MS). It is unclear whether high-dose VD supplementation can be used as an intervention to reduce disease activity. Objectives The study aimed to compare the effects of every other day high- (20,400 IU) versus low-dose (400 IU) cholecalciferol supplementation on clinical and imaging markers of disease activity in patients with relapsing-remitting MS or clinically isolated syndrome. Methods The EVIDIMS (efficacy of vitamin D supplementation in multiple sclerosis) trial was a multicentre randomized/stratified actively controlled explorative phase 2a pilot trial with a double-blind intervention period of 18 months, add on to interferon-beta 1b. Results Fifty-three patients were randomized, and 41 patients completed the study. Cholecalciferol supplementation was well tolerated and safe in both arms. After 18 months, clinical (relapse rates, disability progression) and radiographical (T2-weighted lesion development, contrast-enhancing lesion development, brain atrophy) did not differ between both treatment arms. Post-study power calculations suggested that the sample size was too low to prove the hypothesis. Conclusions The results neither support nor disprove a therapeutic benefit of high-dose VD supplementation but provide a basis for sound sample size estimations in future confirmatory studies. www.clinicaltrials.gov/NCT01440062

引用

页数：8

共 16 条

[1] A phase I/II dose-escalation trial of vitamin D3 and calcium in multiple sclerosis [J].