title: Efficacy and safety of creatine supplementation in childhood-onset systemic lupus erythematosus: a randomized, double-blind, placebo-controlled, crossover trial.
abstract: BACKGROUND
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Clinicaltrials.gov number: NCT01217320.
authors.affiliation: School of Medicine.
authors.forename: A P
authors.initials: AP
authors.lastname: Hayashi
authors.affiliation: School of Medicine.
authors.forename: M Y
authors.initials: MY
authors.lastname: Solis
authors.affiliation: School of Medicine.
authors.forename: M T
authors.initials: MT
authors.lastname: Sapienza
authors.affiliation: School of Medicine.
authors.forename: M C G
authors.initials: MC
authors.lastname: Otaduy
authors.affiliation: School of Medicine.
authors.forename: A L
authors.initials: AL
authors.lastname: de Sá Pinto
authors.affiliation: School of Medicine.
authors.forename: C A
authors.initials: CA
authors.lastname: Silva
authors.affiliation: School of Medicine.
authors.forename: A M E
authors.initials: AM
authors.lastname: Sallum
authors.affiliation: School of Medicine.
authors.forename: R M R
authors.initials: RM
authors.lastname: Pereira
authors.affiliation: School of Medicine School of Physical Education and Sport, University of São Paulo, Brazil gualano@usp.br.
authors.forename: B
authors.initials: B
authors.lastname: Gualano
mesh_terms: D000293:Adolescent; D015308:Anaerobic Threshold; D001823:Body Composition; D016723:Bone Remodeling / Q000502:physiology; D002648:Child; D003401:Creatine / Q000009:adverse effects / Q000627:therapeutic use*; D018592:Cross-Over Studies; D019587:Dietary Supplements / Q000009:adverse effects; D004311:Double-Blind Method; D005080:Exercise Test; D017079:Exercise Tolerance; D005260:Female; D018737:Hand Strength; D006801:Humans; D008180:Lupus Erythematosus, Systemic / Q000188:drug therapy* / Q000503:physiopathology*; D008279:Magnetic Resonance Imaging; D008297:Male; D018482:Muscle, Skeletal / Q000378:metabolism / Q000503:physiopathology*; D010725:Phosphocreatine / Q000378:metabolism; D011788:Quality of Life
chemical_list: D010725:Phosphocreatine; D003401:Creatine
keywords: Phosphorylcreatine; autoimmune disease; muscle metabolism; physical capacity