Carnitine deficiency and the benefits of supplementation in pediatric hemodialysis patients: a double-blinded randomized placebo-controlled trial

Abstract Background Carnitine insufficiency frequently occurs in children undergoing maintenance hemodialysis (HD) and may lead to cardiac dysfunction, muscle weakness, and intradialytic hypotension. Evidence justifying the regular administration of L-carnitine in this population remains limited. This trial assessed the prevalence of carnitine deficiency among pediatric HD patients and evaluated the impact of intravenous L-carnitine administration on cardiac function, body composition and intra-dialytic hypotension. Methodology In this randomized, double-blind, placebo-controlled study, 33 children with end-stage kidney disease and serum free carnitine < 40 µmol/L were enrolled (21 males, 12 females; mean age 11.3 ± 2.4 years). Participants received either intravenous L-carnitine (20 mg/kg dry weight; n = 15) or an equivalent volume of placebo saline ( n = 18) after each dialysis session, three times weekly, for six months. Primary outcomes included lean tissue index (LTI) and echocardiographic indices (left ventricular mass index, ejection fraction and fractional shortening). The study was prospectively registered at ClinicalTrials.gov (Identifier: NCT05948124) prior to enrollment. Results Among 60 patients screened, 35% had serum free carnitine < 20 µmol/L and 31% had levels of 20–40 µmol/L. L-carnitine supplementation significantly improved LTI compared with placebo ( P = 0.015) and led to significant increases in dry body weight ( P = 0.001) and body mass index ( P = 0.002) compared with baseline. A nonsignificant decrease in left ventricular mass index was noted in the treatment group. However, no significant effect on intradialytic hypotension was observed. No therapy-related adverse effects occurred. Conclusions Carnitine deficiency is frequent among children with end-stage kidney disease on HD. Intravenous L-carnitine administration improved lean tissue and anthropometric measures but showed no significant short-term effect on cardiac function and intra-dialytic hypotension.