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Masanori Abe, Takashi Maruyama, Noriaki Maruyama, Seishirou Baba, Hiroyuki Takashima, Tomoyasu Otsuki, Terumi Higuchi, FP716
EFFICACY OF LEVOCARNITINE SUPPLEMENTATION IN IMPROVING LEAN BODY MASS AND PHYSICAL FUNCTION IN PATIENTS ON HEMODIALYSIS: A RANDOMIZED CONTROLLED TRIAL, Nephrology Dialysis Transplantation, Volume 34, Issue Supplement_1, June 2019, gfz106.FP716, https://doi.org/10.1093/ndt/gfz106.FP716 - Share Icon Share
INTRODUCTION: Patients on hemodialysis (HD) are known to develop carnitine deficiency. This may contribute to a number of clinical disorders, including cachexia, dyslipidemia, erythropoiesis stimulating agent-resistant anemia, insulin resistance and glucose intolerance, muscle weakness, and myopathy, as well as intradialytic symptoms, including muscle cramps, hypotension, and cardiac arrhythmias. However, the efficacy of levocarnitine (L-carnitine) supplementation on lean body mass (LBM) and physical function have not been studied and remain unclear. This study aimed to determine the effect of L-carnitine supplementation on physical and nutritional status in patients undergoing hemodialysis.
METHODS: In this multicenter, prospective, open-label, parallel, randomized, controlled trial, patients on maintenance hemodialysis who developed carnitine deficiency were randomly assigned to receive injections of L-carnitine 1,000 mg 3 times weekly after hemodialysis sessions (L-carnitine group) or no injections (control group) with monitoring for 12 months. All eligible participants were required to undergo dual-energy X-ray absorptiometry (DXA) scans to determine their LBM, fat mass, and skeletal muscle mass. The primary efficacy endpoints were physical function-related parameters, including dry weight, body mass index (BMI), mid-upper arm muscle area (AMA), hand grip strength, and LBM, which were measured as the magnitude of change from baseline and compared between the two groups. The secondary endpoints were the differences in magnitude of change from baseline in clinical parameters between the two groups.
RESULTS: Data for 84 of the 91 patients were available for analysis (L-carnitine group, n = 42; control group, n = 42). Dry weight and BMI did not significantly change in the L-carnitine group, but significantly decreased in the control group. AMA did not change significantly in the L-carnitine group but decreased significantly in the control group; the difference in mean AMA between the groups was 6.22% (95% confidence interval [CI] 1.90–10.5; P = 0.037). Hand grip strength did not change significantly in the L-carnitine group, but decreased significantly in the control group. The difference in change in hand grip strength between the groups was 4.27% (95% CI 0.42–8.12; P = 0.030). Furthermore, LBM did not change significantly in the L-carnitine group but decreased significantly in the control group; the difference in mean LBM between the groups was 2.95% (95% CI 1.28–4.61; P = 0.0007).
CONCLUSIONS: Our findings showed the utility of L-carnitine injection for prevention of muscle weakness in patients who develop carnitine deficiency while on HD. The benefits of L-carnitine supplementation in these patients include maintenance of both physical function and LBM. Further large-scale clinical studies would be needed to establish L-carnitine supplementation significantly influences mortality rates for dialysis patients.
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