Adjunctive vitamin D for the treatment of active juvenile idiopathic arthritis: An open-label, prospective, randomized controlled trial.

Vitamin D has an important immunomodulatory effect, but no trial has examined the effect of boosting serum levels of 25-hydroxyvitamin D (25OHD) in individuals with juvenile idiopathic arthritis (JIA). The aim of the present study was to assess whether vitamin D supplementation reduced disease activity and adjusted/maintained bone mass in patients with active JIA. A 24-week randomized trial was undertaken at Children's Hospital of Chongqing Medical University. Treatment-naive patients with JIA were randomly assigned (1:1) to one of two groups: Standard treatment with high dose oral cholecalciferol [2,000 IU per day; experimental group (EG)] or without supplementation [control group (CG)]. The primary outcomes were the 27-joint Juvenile Arthritis Disease Activity Score (JADAS-27 score), the Z-score for bone mineral density (BMD), and serum levels of 25OHD. A per-protocol analysis set approach was used. The Mann-Whitney U test was the main tool used for data analysis. A total of 42 participants were assigned randomly to the EG (n=20) or the CG (n=22); of these, 36 (n=18 and n=18, respectively) were included in per-protocol analysis. After 24 weeks, the mean level of 25OHD in the EG was higher than that in the CG (P<0.05). At the end of the intervention, there were no clear differences between the two groups in terms of BMD or JADAS-27 score (both P>0.05). Cholecalciferol supplementation (2000 IU/day) for 24 weeks raised serum levels of 25OHD in JIA patients but did not reduce disease activity or improve BMD (registration no. ChiCTR-INR-16009235; Date of Registration: 2016-10-12).