Efficacy of Vitamin D Supplementation in Multiple Sclerosis (EVIDIMS Trial): study protocol for a randomized controlled trial

Table 1 Time schedule of regular study visits and outcome parameters

	Screening (Week -2)	V0 (Baseline) ± 7 days	V1(Month 1) ± 7 days	V2 (Month 3) ± 7 days	V3 (Month 6) ± 14 days	V4 (Month 9) ± 14 days	V5 (Month 12) ± 14 days	V6 (Month 18) ± 21 days	Follow up (Month 24) ± 8 weeks (optional)
Informed consent	√
In/exclusion criteria	√	√
Randomization		√
Evaluation of relapses	√	√	√	√	√	√	√	√	√
Concomitant medication	√	√	√	√	√	√	√	√	√
Physical examination	√				√		√	√
Vital signs	√	√	√	√	√	√	√	√	√
MSFC	√				√		√	√	√
EDSS	√				√		√	√	√
ECG	√							√
Safety lab	√	√	√	√	√	√	√	√
Immunology blood sampling	√				√		√	√
MRI	√						√	√	√
OCT	√						√	√	√
Visual contrast parameters	√						√	√	√
Quantitative motor function tests	√						√	√	√
Questionnaires (fatigue, depression, QoL)	√				√		√	√	√
Cognitive testing (SDMT, FST)	√							√	√
Drug account			√	√	√	√	√	√
Adverse event reporting			√	√	√	√	√	√

ISSN: 1745-6215