Efficacy and safety of creatine supplementation in childhood-onset systemic lupus erythematosus: a randomized, double-blind, placebo-controlled, crossover trial
Hayashi AP, Solis MY, Sapienza MT, Otaduy MC, de Sá Pinto AL, Silva CA, Sallum AM, Pereira RM, Gualano B
Lupus · 23 citas
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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 no declarada
Publicación
- Publicado
- 2014-08-18 · Lupus · vol. 23 · número 14 · págs. 1500–1511
- Editorial
- SAGE Publishing
- Citado
- 35 citas · más que el 73% de estudios similares · 1.0× el promedio de su campo
- Referencias
- 51 trabajos
- Acceso
- De pago
- Áreas de investigación
- Muscle metabolism and nutrition · Systemic Lupus Erythematosus Research · Nutrition and Health in Aging
- Palabras clave
- creatine supplementation, pediatric lupus, muscle function, lean body mass, body composition, bone remodeling, aerobic conditioning, quality of life, renal function, safety, pediatric rheumatic diseases, dietary intake, phosphorus magnetic resonance spectroscopy, Timed Up and Go test, grip strength, 51Cr-EDTA clearance
- MeSH
- muscle, skeletal, humans, lupus erythematosus, systemic, creatine, phosphocreatine, magnetic resonance imaging, exercise test, hand strength, cross-over studies, double-blind method, bone remodeling, body composition, anaerobic threshold, exercise tolerance, quality of life, dietary supplements, adolescent, child, female, male
9 autores
- A P Hayashi
- Marina Yázigi Solis
- Marcelo Tatit Sapienza
- Maria Concepción García Otaduy
- Ana Lúcia de Sá Pinto
- Clóvis A. Silva
- Adriana Maluf Elias Sallum
- Rosa Maria Rodrigues Pereira
- Bruno Gualano🇧🇷 · autor de correspondenciaUniversidade de São Paulo
Resumen
El texto original del estudio, en el idioma en que se publicó.
Introduction
Creatine supplementation has emerged as a promising non-pharmacological therapeutic strategy to counteract muscle dysfunction and low lean mass in a variety of conditions, including in pediatric and rheumatic diseases. The objective of this study was to examine the efficacy and safety of creatine supplementation in childhood systemic lupus erythematosus (C-SLE).
Methods
C-SLE patients with mild disease activity (n = 15) received placebo or creatine supplementation in a randomized fashion using a crossover, double-blind, repeated-measures design. The participants were assessed at baseline and after 12 weeks in each arm, interspersed by an eight-week washout period. The primary outcomes were muscle function, as assessed by a battery of tests including one-maximum repetition (1-RM) tests, the timed-up-and-go test, the timed-stands test, and the handgrip test. Secondary outcomes included body composition, biochemical markers of bone remodeling, aerobic conditioning, quality of life, and physical capacity. Possible differences in dietary intake were assessed by three 24-hour dietary recalls. Muscle phosphorylcreatine content was measured through phosphorus magnetic resonance spectroscopy (31 P-MRS). The safety of the intervention was assessed by laboratory parameters, and kidney function was measured by (51)Cr-EDTA clearance. Additionally, self-reported adverse events were recorded throughout the trial.
Results
Intramuscular phosphorylcreatine content was not significantly different between creatine and placebo before or after the intervention (creatine-Pre: 20.5 ± 2.6, Post: 20.4 ± 4.1, placebo-Pre: 19.8 ± 2.0; Post: 20.2 ± 3.2 mmol/kg wet muscle; p = 0.70 for interaction between conditions). In addition, probably as a consequence of the lack of change in intramuscular phosphorylcreatine content, there were no significant changes between placebo and creatine for any muscle function and aerobic conditioning parameters, lean mass, fat mass, bone mass, and quality of life scores (p > 0.05). The (51)Cr-EDTA clearance was not altered by creatine supplementation and no side effects were noticed.
Conclusion
A 12-week creatine supplementation protocol at 0.1 g/kg/d is well tolerated and free of adverse effects but did not affect intramuscular phosphorylcreatine, muscle function, free-fat mass or quality of life in non-active C-SLE patients.
Trial registration
Clinicaltrials.gov number: NCT01217320.
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