Efficacy of Vitamin D Supplementation in Multiple Sclerosis (EVIDIMS)

Conditions

Multiple Sclerosis

Brief summary

Examination of efficacy, safety and tolerability of vitamin D3 in the treatment of Multiple Sclerosis (MS).

Priscilla Bäcker‐Koduah, Carmen Infante‐Duarte, Federico Ivaldi, Antonio Uccelli, Judith Bellmann–Strobl et al. (11 authors)

Annals of Clinical and Translational Neurology2020-08-2311 citations

10.1002/acn3.51148

Vitamin D and Disease Severity in Multiple Sclerosis—Baseline Data From the Randomized Controlled Trial (EVIDIMS)

Priscilla Bäcker‐Koduah, Judith Bellmann–Strobl, Michael Scheel, Jens Wuerfel, Klaus‐Dieter Wernecke et al. (8 authors)

Frontiers in Neurology2020-02-2528 citations

10.3389/fneur.2020.00129

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

Jan Dörr, Priscilla Bäcker‐Koduah, Klaus‐Dieter Wernecke, Elke Becker, Frank Hoffmann et al. (14 authors)

Multiple Sclerosis Journal - Experimental Translational and Clinical2020-01-0147 citations

10.1177/2055217320903474

Efficacy of vitamin D supplementation in multiple sclerosis (EVIDIMS Trial): study protocol for a randomized controlled trial.

Dörr J, Ohlraun S, Skarabis H, Paul F.

2012-02-0865 citations

10.1186/1745-6215-13-15

Interventions

DRUGVerum arm receiving Vitamin D oil

oil: 20000 IU/g tablet: 400 IU/g every second day

DRUGlow dose arm receiving neutral oil and 400 IU/g of Vitamin D every second day

neutral oil and a low dose of vitamin D

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

No

Inclusion criteria

* Informed consent * Age between 18 and 65 at randomization * Relapsing-remitting MS according to the revised McDonald-Criteria (2005) * EDSS ≤ 6,0 * Stable immunomodulatory treatment for at least 3 months * Sufficient birth control (Pearl-Index \<1) and negative pregnancy test at screening/randomization

Exclusion criteria

* Any other MS-course than RRMS * Treatment with high dose vitamin D within 6 months prior to randomization * Patients who have received over the last three months prior to randomization, an immunomodulatory therapy with the exception of IFN-β1b (Betaferon ®) * Any condition that could interfere with MRI or other study related investigation * Intolerability to Gd-DTPA * Hypersensitivity to the drug Colecalciferol * Patients with sarcoidosis * Presence or history of nephrolithiasis * Pseudohypoparathyroidism * Clinically relevant dysfunction of liver, bone narrow or kidney defined by the following laboratory values: * HB \<8.5 g / dl * WBC \<2.5 / nl * platelet count \<100/nl * Creatinine clearance by Cockcroft-Gault formula: Cl \<110ml/min (male) and Cl \<95ml/min (female) * AST / ALT\> 3.5 times higher than the upper reference value * bilirubin\> 2.0 mg / dl * hypercalcaemia\> 2.7 mmol / l * calcium / creatinine ratio in urine\> 1 * Treatment with hydrochlorothiazide, digitoxin, digoxin, phenytoin, barbiturates * Pregnancy or lactation period * Participation in any clinical study within 3 months before or at any time during study * Any medical, psychiatric or other condition that could interfere with the patient's ability to understand and give the informed consent, to comply with the protocol or to finish the study any ruling commitment or placement in an institution

Design outcomes

Primary

Measure	Time frame	Description
Efficacy parameters	1 day	efficacy of Vitamin D (high dose) in patients with Multiple Sclerosis compared to low dose of Vitamin D

Secondary

Measure	Time frame	Description
Safety & tolerability parameters	1 day	Routine laboratory, vital signs, physical examination, ECG, AE reporting, Quality of Life

Countries

Germany

Outcome results

None listed