The vitamin D to ameliorate multiple sclerosis (VIDAMS) trial: study design for a multicenter, randomized, double-blind controlled trial of vitamin D in multiple sclerosis
P Bhargava, S Cassard, SU Steele, C Azevedo… - Contemporary clinical …, 2014 - Elsevier
Contemporary clinical trials, 2014•Elsevier
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 …
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 …
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 D3 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.
Elsevier