Safety and immunologic effects of high- vs low-dose XXXX in @entity15 .

@entity1 @entity404 @entity3875 @entity14257 @entity15
OBJECTIVE: To study the safety profile and characterize the immunologic effects of high- vs low-dose @entity3875 supplementation in @entity1 with @entity15 ( @entity15 ). METHODS: In this double-blind, single-center randomized pilot study, 40 @entity1 with relapsing-remitting @entity15 were randomized to receive 10,400 IU or 800 IU @entity3875 daily for 6 months. Assessments were performed at baseline and 3 and 6 months. RESULTS: Mean increase of @entity14257 levels from baseline to final visit was larger in the high-dose group (34.9 ng/mL; 95% confidence interval [CI] 25.0-44.7 ng/mL) than in the low-dose group (6.9 ng/mL; 95% CI 1.0-13.7 ng/mL). Adverse events were minor and did not differ between the 2 groups. Two relapses occurred, one in each treatment arm. In the high-dose group, we found a reduction in the proportion of interleukin-17(+) @entity404 (+) T cells (p = 0.016), CD161(+) @entity404 (+) T cells (p = 0.03), and effector memory @entity404 (+) T cells (p = 0.021) with a concomitant increase in the proportion of central memory @entity404 (+) T cells (p = 0.018) and naive @entity404 (+) T cells (p = 0.04). These effects were not observed in the low-dose group. CONCLUSIONS: @entity3875 supplementation with 10,400 IU daily is safe and tolerable in @entity1 with @entity15 and exhibits in vivo pleiotropic immunomodulatory effects in @entity15 , which include reduction of interleukin-17 production by @entity404 (+) T cells and decreased proportion of effector memory @entity404 (+) T cells with concomitant increase in central memory @entity404 (+) T cells and naive @entity404 (+) T cells. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that @entity3875 supplementation with 10,400 IU daily is safe and well-tolerated in @entity1 with @entity15 and exhibits in vivo pleiotropic immunomodulatory effects.
