Trial reportTrials2012
Efficacy of vitamin D supplementation in multiple sclerosis (EVIDIMS Trial): study protocol for a randomized controlled trial.
Trial report in Trials, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 38 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase II Study of Efficacy of Vitamin D Supplementation in Multiple Sclerosis
Depression and Immune Function in Multiple Sclerosis (MS)
Who cites it
38 citing papers in PubMed, 2 syntheses or guidelines pooled it, 92 citations in OpenAlex.
- Influence of Diet in Multiple Sclerosis: A Systematic Review.Advances in nutrition (Bethesda, Md.) · 2017Pooled it
- A systematic review of randomized, double-blind, placebo-controlled trials examining the clinical efficacy of vitamin D in multiple sclerosis.Neuroepidemiology · 2013Pooled it
- Effect of vitamin D supplementation on N-glycan branching and cellular immunophenotypes in MS.Annals of clinical and translational neurology · 2020Trial
- Randomized trial of daily high-dose vitamin DNeurology · 2019Trial
- Safety and immunologic effects of high- vs low-dose cholecalciferol in multiple sclerosis.Neurology · 2016Trial
- Trial
- Review
- Vitamin D and Disease Severity in Multiple Sclerosis-Baseline Data From the Randomized Controlled Trial (EVIDIMS).Frontiers in neurology · 2020Article
- The Gut Microbiota in Multiple Sclerosis: An Overview of Clinical Trials.Cell transplantation · 2019Article
- High dose vitamin D exacerbates central nervous system autoimmunity by raising T-cell excitatory calcium.Brain : a journal of neurology · 2019Article
- Metastatic calcinosis cutis due to refractory hypercalcaemia responsive to denosumab in a patient with multiple sclerosis.BMJ case reports · 2019Article
- Vitamin D Supplementation in Central Nervous System Demyelinating Disease-Enough Is Enough.International journal of molecular sciences · 2019Review
- Focus on 1,25-Dihydroxyvitamin D3 in the Peripheral Nervous System.Frontiers in neuroscience · 2019Review
- Vitamin D and Multiple Sclerosis: A Comprehensive Review.Neurology and therapy · 2018Review
- [Optical coherence tomography in neuromyelitis optica spectrum disorders].Der Nervenarzt · 2017Review
- Vitamin D in the prevention, prediction and treatment of neurodegenerative and neuroinflammatory diseases.The EPMA journal · 2017Review
- Vitamin D and Neurological Diseases: An Endocrine View.International journal of molecular sciences · 2017Review
- Wellness and the Role of Comorbidities in Multiple Sclerosis.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2017Review
- Vitamin D: not just the bone. Evidence for beneficial pleiotropic extraskeletal effects.Eating and weight disorders : EWD · 2017Review
- Multiple sclerosis patients have a diminished serologic response to vitamin D supplementation compared to healthy controls.Multiple sclerosis (Houndmills, Basingstoke, England) · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMultiple sclerosis is the most common chronic inflammatory disease of the central nervous system in young adults. Despite the fact that numerous lines of evidence link both the risk of disease development and the disease course to the serum level of 25-hydroxyvitamin D it still remains elusive whether multiple sclerosis patients benefit from boosting the serum level of 25-hydroxyvitamin D, mainly because interventional clinical trials that directly address the therapeutic effects of vitamin D in multiple sclerosis are sparse. We here present the protocol of an interventional clinical phase II study to test the hypothesis, that high-dose vitamin D supplementation of multiple sclerosis patients is safe and superior to low-dose supplementation with respect to beneficial therapeutic effects. METHODS/
designThe EVIDIMS trial is a German multi-center, stratified, randomized, controlled and double-blind clinical phase II pilot study. Eighty patients with the diagnosis of definite multiple sclerosis or clinically isolated syndrome who are on a stable immunomodulatory treatment with interferon-β1b will be randomized to additionally receive either high-dose (average daily dose 10.200 IU) or low-dose (average daily dose 200 IU) cholecalciferol for a total period of 18 months. The primary outcome measure is the number of new lesions detected on T2-weighted cranial MRI at 3 tesla. Secondary endpoints include additional magnetic resonance imaging and optical coherence tomography parameters for neuroinflammation and -degeneration, clinical parameters for disease activity, as well as cognition, fatigue, depression, and quality of life. Safety and tolerability of high-dose vitamin D supplementation are further outcome parameters. DISCUSSION: In light of the discrepancy between existing epidemiological and preclinical data on the one hand and available clinical data on the other the EVIDIMS trial will substantially contribute to the evaluation of the efficacy of high-dose vitamin D supplementation in MS patients. The study design presented here fulfills the criteria of a high-quality clinical phase II trial in MS.
trial registrationClinicalTrials.gov Identifier: NCT01440062.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.