Efficacy of Vitamin D Supplementation in Multiple Sclerosis (EVIDIMS)
Phase II Study of Efficacy of Vitamin D Supplementation in Multiple Sclerosis
What it found
The trial ended early for another reason (see below).
18 months
Read by software from the paper's abstract
What was tested
Treatment tested
- Cholecalciferol
Vitamin D receptor agonist
What it measured
Main measures
Efficacy parameters
1 day
Other measures (1)
Safety & tolerability parameters
1 day
Quality of life (reported by participants)Safety
Who could take part
Relapsing MS · 18 to 65
Show the full criteria
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Examination of efficacy, safety and tolerability of vitamin D3 in the treatment of Multiple Sclerosis (MS).
Papers
Results
Effect of vitamin D supplementation on N-glycan branching and cellular immunophenotypes in MS.Ann Clin Transl Neurol · 2020
Results
Efficacy of vitamin D supplementation in multiple sclerosis (EVIDIMS Trial): study protocol for a randomized controlled trial.Trials · 2012
Results
Dorr J, Backer-Koduah P, Wernecke KD, Becker E, Hoffmann F, Faiss J, Brockmeier B, Hoffmann O, Anvari K, Wuerfel J, Piper SK, Bellmann-Strobl J, Brandt AU, Paul F. High-dose vitamin D supplementation in multiple sclerosis - results from the randomized EVIDIMS (efficacy of vitamin D supplementation in multiple sclerosis) trial. Mult Scler J Exp Transl Clin. 2020 Jan 24;6(1):2055217320903474. doi: 1After 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.
Read by software from the paper's abstract
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History
Started
Dec 2011
Main results due
Jun 2017
Finished
Jun 2017