Research Article

A Randomised, Double-Blind, Placebo-Controlled Trial with Vitamin D3 in MS: Subgroup Analysis of Patients with Baseline Disease Activity Despite Interferon Treatment

Table 2

MRI results in the vitamin D-and placebo-treated active subgroup patients.

Vitamin DPlacebo 𝑃 value

T2 BOD (mm3),
median (SE)
Baseline 𝑛 = 1 5 4391 (2305) 𝑛 = 1 5 9930 (2375)0.105
Change from baseline 𝑛 = 1 3 104 (240) 𝑛 = 1 4 570 (3259)
Number of T1-enhancing lesions,
mean (SD)
Baseline 𝑛 = 1 5 1.5 (3.6) 𝑛 = 1 5 1.5 (2.9)
Month 12 𝑛 = 1 3 0.1 (0.3) 𝑛 = 1 4 1.5 (5.0)0.027*
Patients with T1-enhancing lesions ( 𝑛 ,%)Baseline 𝑛 = 1 5 6 (40%) 𝑛 = 1 5 6 (40%)
Month 12 𝑛 = 1 3 1 (8%) 𝑛 = 1 4 3 (21%)
Number of new or enlarging T2/PD lesions, median (SD)Month 12 𝑛 = 1 3 0.61 (1.26) 𝑛 = 1 4 1.85 (2.44)0.132
Patients with new or enlarging lesions on T2/PD, mean (SD)Month 12 𝑛 = 1 3 3 (23%) 𝑛 = 1 3 8 (57%)NS
MRI activity ( 𝑛 ,%)Baseline 𝑛 = 1 5 6 (40%) 𝑛 = 1 5 6 (40%)0.080
Month 12 𝑛 = 1 3 3 (23%) 𝑛 = 1 4 8 (57%)

BOD: burden of disease; MRI activity: Gadolinium-enhancing T1 lesions or new/enlarging T2 lesions; 𝑛 : number of patients. *Indicates statistically significant. NS: not significant.