Pavan Bhargava1, Sandra Cassard1, Sonya U Steele1, Christina Azevedo2, Daniel Pelletier2, Elizabeth A Sugar3, Emmanuelle Waubant4, Ellen M Mowry5. 1. Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA. 2. Yale Multiple Sclerosis Center Department of Neurology, Yale University, CT, USA. 3. Department of Biostatistics, Johns Hopkins School of Public Health, Baltimore, MD, USA. 4. Department of Neurology, University of California San Francisco, San Francisco, CA, USA. 5. Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: emowry1@jhmi.edu.
Abstract
BACKGROUND: Lower levels of vitamin D are associated with increased MS risk and with greater clinical and brain MRI activity in established relapsing MS. OBJECTIVE: The VIDAMS trial (NCT01490502) is evaluating whether high-dose vitamin D supplementation reduces the risk of MS activity. DESIGN/ METHODS:Eligibility criteria include diagnosis of RRMS, age 18 to 50 years, and Expanded Disability Status Scale ≤4.0. Disease duration and activity requirements depend on whether 2005 or 2010 criteria are used for diagnosis. Enrollment is restricted based on prior MS therapy exposure and recent vitamin D use. After completing a one-month run-in of glatiramer acetate, 172 patients will be randomized 1:1 to oral vitamin D(3) 5000 IU versus 600 IU daily. Clinical visits occur every 12 weeks for 96 weeks. RESULTS: Sixteen sites throughout the United States are participating in the trial. Complete enrollment is expected by late 2014, with follow-up through 2016. No interim analyses are planned. The primary outcome for the trial is the proportion of patients experiencing a relapse in each group. Other clinical, patient-reported, and MRI outcomes will be evaluated. CONCLUSIONS: The VIDAMS trial will provide critical information about the safety and efficacy of vitamin D therapy in RRMS, with implications for MS patients worldwide.
RCT Entities:
BACKGROUND: Lower levels of vitamin D are associated with increased MS risk and with greater clinical and brain MRI activity in established relapsing MS. OBJECTIVE: The VIDAMS trial (NCT01490502) is evaluating whether high-dose vitamin D supplementation reduces the risk of MS activity. DESIGN/ METHODS: Eligibility criteria include diagnosis of RRMS, age 18 to 50 years, and Expanded Disability Status Scale ≤4.0. Disease duration and activity requirements depend on whether 2005 or 2010 criteria are used for diagnosis. Enrollment is restricted based on prior MS therapy exposure and recent vitamin D use. After completing a one-month run-in of glatiramer acetate, 172 patients will be randomized 1:1 to oral vitamin D(3) 5000 IU versus 600 IU daily. Clinical visits occur every 12 weeks for 96 weeks. RESULTS: Sixteen sites throughout the United States are participating in the trial. Complete enrollment is expected by late 2014, with follow-up through 2016. No interim analyses are planned. The primary outcome for the trial is the proportion of patients experiencing a relapse in each group. Other clinical, patient-reported, and MRI outcomes will be evaluated. CONCLUSIONS: The VIDAMS trial will provide critical information about the safety and efficacy of vitamin D therapy in RRMS, with implications for MS patients worldwide.
Authors: Elias S Sotirchos; Pavan Bhargava; Christopher Eckstein; Keith Van Haren; Moira Baynes; Achilles Ntranos; Anne Gocke; Lawrence Steinman; Ellen M Mowry; Peter A Calabresi Journal: Neurology Date: 2015-12-30 Impact factor: 9.910
Authors: Darius Häusler; Sebastian Torke; Evelyn Peelen; Thomas Bertsch; Marija Djukic; Roland Nau; Catherine Larochelle; Scott S Zamvil; Wolfgang Brück; Martin S Weber Journal: Brain Date: 2019-09-01 Impact factor: 13.501
Authors: Pavan Bhargava; Sonya U Steele; Emmanuelle Waubant; Nisha R Revirajan; Jacqueline Marcus; Marieme Dembele; Sandra D Cassard; Bruce W Hollis; Ciprian Crainiceanu; Ellen M Mowry Journal: Mult Scler Date: 2015-08-18 Impact factor: 6.312