A randomized double-blind placebo-controlled trial of vitamin D supplementation in adolescents and young adults with Juvenile-onset SLE: Improvement in disease activity and fatigue scores
Arthritis Care and Research, DOI: 10.1002/acr.22621
Glauce L Lima1, Juliane Paupitz1, Nadia E Aikawa1,2, Liliam Takayama1, Eloisa Bonfa1 andRosa M. R. Pereira1,*
1Division of Rheumatology, Faculdade de Medicina da Universidade de São Paulo, Brazil
2Pediatric Rheumatology Unit, Faculdade de Medicina da Universidade de São Paulo, Brazil
*Corresponding author: Rosa Maria Rodrigues Pereira, Faculdade de Medicina da USP, Reumatologia, Av Dr Arnaldo, 455, 3º andar, sala 3193, Sao Paulo - SP - Brazil, 01246-903, Phone number: +55 11 30618594; Fax: +55 11 30617490, e-mail: rosamariarp at yahoo.com
Purpose: Vitamin D has an important immunomodulatory effect, but there are no trials that directly addressed the boosting of serum levels of 25-hydroxyvitamin D (25OHD) in Juvenile-onset Systemic Lupus Erythematosus (JoSLE). The aim of this study was to evaluate the effect of vitamin D supplementation on disease activity and fatigue in JoSLE.
Methods: This study was a randomized double-blind placebo-controlled 24-week trial. Forty JoSLE patients were randomized (1:1) to receive oral cholecalciferol 50,000 IU/week (JoSLE-VitD) or placebo (JoSLE-PL). Medications remained stable throughout the study. Serum levels of 25OHD were measured using radioimmunoassay. Disease activity was assessed using the SLE Disease Activity Index (SLEDAI) and the European Consensus Lupus Activity Measurement (ECLAM). Fatigue was assessed using the Kids Fatigue Severity Scale (K-FSS).
Results: At baseline, groups were similar regarding, age, body mass index, organ involvement, glucocorticoid dose, use of immunosuppressive drugs, SLEDAI, ECLAM, K-FSS and levels of 25OHD. After 24 weeks, the mean level of 25OHD was higher in the JoSLE-VitD group than in the JoSLE-PL (p<0.001).At the end of intervention, a significant improvement in SLEDAI (p=0.010) and a tendency for ECLAM (p=0.076) was observed in the JoSLE-VitD group compared to the JoSLE-PL. Regarding fatigue evaluation, a reduction of fatigue related to social life score was found in the JoSLE-VitD group compared to the JoSLE-PL group (p=0.008). Cholecalciferol was well tolerated with no serious adverse events.
Conclusion: This study suggests that cholecalciferol supplementation for 24 weeks is effective in decreasing disease activity and improving fatigue in JoSLE patients. This article is protected by copyright. All rights reserved.
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|Fatigue Easily||3.65 ==> 3.05|
| 4.4 ==> 4.75|
|Fatigue interfere with social life||3.55 ==> 2.60|
|3.50 ==> 4.1|
|Vitamin D Level at 6 months||31 ng||17 ng|
- This was just barely enough vitamin D on average to make a difference
- If they had increased the dose for higher BMI subjects the average vitamin D level would have increased from 31 ng to approx 40 ng
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