Session Information
Title: Pediatric Rheumatology - Clinical and Therapeutic Aspects: Pediatric Systemic Lupus Erythematosus
Session Type: Abstract Submissions (ACR)
Background/Purpose
Vitamin D has an important immunomodulatory effect but there are no clinical trials that directly addressed the benefit from boosting the serum level of 25-hydroxyvitamin D in Juvenile-onset Systemic Lupus Erythematosus (JoSLE). The aim of this study is, therefore, to evaluate the vitamin D supplementation in disease activity scores and fatigue in JoSLE patients.
Methods
This study was a randomized double-blind placebo-controlled 24-week trial. Forty female JoSLE patients were randomized (1:1) to receive either oral cholecalciferol 50,000 IU/week (JoSLE-Vit D) or placebo (JoSLE-PL). Mean glucocorticoid dose and immunosuppressive medications remained stable throughout the study. Serum levels of 25 hydroxyvitamin D (25OHD) were measured using a radioimmunoassay technique (DiaSorin, Stillwater, Minnesota, USA). Disease activity was assessed by the SLE Disease Activity Index (SLEDAI) and by European Consensus Lupus Activity Measurement (ECLAM). Fatigue was assessed using Kids Fatigue Severity Scale (K-FSS), scores with an adapted range from 1 to 5 with low levels indicating higher fatigue. Longitudinal regression models were used to estimate the association between levels of 25OHD, disease activity and fatigue. T-test or Mann-Whitney test were performed to see differences between groups.
Results
Groups were similar regarding age (p=0.61), body mass index (p=0.28), frequency of organ involvements (p>0.05), mean glucocorticoid dose (11.90 ± 9.5 vs. 15.30 ± 14.82 mg/day, p=0.38) and frequency of immunosuppressive drugs (84 vs. 75%, p=0.490), SLEDAI (3.57 ± 2.87 vs. 4.35 ± 4.22, p=0.51), ECLAM (2.31 ± 1.74 vs. 2.35 ± 2.09, p=0.95), and fatigue scores at baseline (3.21 ± 0.90 vs. 2.90 ± 0.88, p=0.29). There was also no difference in the serum levels of 25OHD at the baseline between JoSLE-Vitamin D and JoSLE-PL (19.1 ± 6.6 vs. 19.5 ± 4.5 ng/mL, p=0.81). After 24 weeks of supplementation, the mean level of 25OHD was higher in JoSLE-Vit. D group compared to JoSLE-PL group (31.15 ± 8.89 vs. 16.56 ± 5.88 ng/mL, p<0.001). At the end of intervention, a decrease in SLEDAI score was observed in JoSLE-Vit. D compared to JoSLE-PL [Δ(final – baseline) SLEDAI: -0.58 ± 3.11 vs. 1.2 ± 3.67, p=0.01)] and a tendency of decrease in ECLAM score: (ΔECLAM: -0.63 ± 1.11 vs. 0.3 ± 0.20, p=0.083). Regarding fatigue evaluation, an improvement of fatigue related to social life score was found in JoSLE-VD compared to JoSLE-PL group (ΔFatigue: 0.47 ± 1.07 vs.-0.2 ± 0.95 vs. p=0.024). Cholecalciferol (50,000IU/week) intervention was well tolerated with no serious adverse events.
Conclusion
This study suggests that cholecalciferol supplementation 50,000IU/week for 6 months is effective to decrease disease activity and improve fatigue in JoSLE patients. (NCT01892748).
Disclosure:
G. Lima,
None;
J. Paupitz,
None;
L. Takayama,
None;
E. Bonfa,
None;
R. M. R. Pereira,
None.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/a-randomized-double-blind-placebo-controlled-trial-of-vitamin-d-supplementation-in-juvenile-onset-systemic-lupus-erythematosus-improvement-in-disease-activity-and-fatigue-scores/