Vitamin D Supplementation in Adolescents and Young Adults With Juvenile Systemic Lupus Erythematosus for Improvement in Disease Activity and Fatigue Scores: A Randomized, Double-Blind, Placebo-Controlled Trial
Lima GL, Paupitz J, Aikawa NE, Takayama L, Bonfa E, Pereira RM
Arthritis care & research · 116 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Organización sin fines de lucro
- Federico and Elvia Faggin Foundation
- Gobierno
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior
- Gobierno
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Organización sin fines de lucro
- Federico Foundation
- Subvenciones
- Conselho Nacional de Desenvolvimento Científico e Tecnológico (472754/2013-0); Conselho Nacional de Desenvolvimento Científico e Tecnológico (#301411/2009-3); Conselho Nacional de Desenvolvimento Científico e Tecnológico (#301805/2013-0)
Según 4 financiadores declarados.
Publicación
- Publicado
- 2015-05-18 · Arthritis Care Res (Hoboken) · vol. 68 · número 1 · págs. 91–98
- Editorial
- Wiley
- Citado
- 165 citas · más que el 99% de estudios similares · 13.2× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 48 trabajos
- Acceso
- Acceso abierto (copia en repositorio) · OTHER-OA
- Áreas de investigación
- Systemic Lupus Erythematosus Research · Vitamin D Research Studies · Systemic Sclerosis and Related Diseases
- Palabras clave
- vitamin D supplementation, vitamin D3, pediatric lupus, 25-hydroxyvitamin D, disease activity, fatigue, adolescents and young adults, immunomodulation, SLEDAI, ECLAM, safety and tolerability, glucocorticoid dose
- MeSH
- humans, lupus erythematosus, systemic, fatigue, cholecalciferol, vitamins, vitamin d, immunosuppressive agents, glucocorticoids, radioimmunoassay, treatment outcome, administration, oral, severity of illness index, double-blind method, age factors, time factors, dietary supplements, adolescent, brazil, female, male, young adult, biomarkers
6 autores
- Glauce Leão Lima🇧🇷Universidade de São Paulo
- Juliane Aline Paupitz🇧🇷Universidade de São Paulo
- Nádia Emi Aikawa🇧🇷Universidade de São Paulo
- Liliam Takayama🇧🇷Universidade de São Paulo
- Eloísa Bonfá🇧🇷Universidade de São Paulo
- Rosa Maria Rodrigues Pereira🇧🇷 · autor de correspondenciaUniversidade de São Paulo
Resumen
El texto original del estudio, en el idioma en que se publicó.
Objective
Vitamin D has an important immunomodulatory effect, but there are no trials that directly address the boosting of serum levels of 25-hydroxyvitamin D (25[OH]D) in juvenile-onset systemic lupus erythematosus (SLE). The aim of this study was to evaluate the effect of vitamin D supplementation on disease activity and fatigue in juvenile-onset SLE.
Methods
This study was a randomized, double-blind, placebo-controlled, 24-week trial. Forty juvenile-onset SLE patients were randomized (1:1) to receive oral cholecalciferol 50,000 IU/week (juvenile-onset SLE-VitD) or placebo (juvenile-onset SLE-PL). Medications remained stable throughout the study. Serum levels of 25(OH)D were measured using radioimmunoassay. Disease activity was assessed using the Systemic Lupus Erythematosus 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 25(OH)D. After 24 weeks, the mean level of 25(OH)D was higher in the juvenile-onset SLE-VitD group than in the juvenile-onset SLE-PL group (P < 0.001). At the end of the intervention, a significant improvement in SLEDAI (P = 0.010) and in ECLAM (P = 0.006) was observed in the juvenile-onset SLE-VitD group compared to the juvenile-onset SLE-PL group. Regarding fatigue evaluation, a reduction of fatigue related to social life score was found in the juvenile-onset SLE-VitD group compared to the juvenile-onset SLE-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 juvenile-onset SLE patients.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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