title: Coenzyme Q10 absorption and tolerance in children with Down syndrome: a dose-ranging trial.
abstract: Controlled studies of coenzyme Q(10) dosing and tolerance have been reported in adults, but not in pediatric patients. This study compares low- and high-dose coenzyme Q(10) (LiQ-NOL syrup) absorption and tolerance in children with Down syndrome. After a 1-month low-dose (1.0 mg/kg/day) run-in period, all participants received high-dose coenzyme Q(10) (10.0 mg/kg/day) for two additional months (in randomized sequence as one daily dose or split into two daily doses). Chemistry profiles and complete blood counts were determined just before and at the study completion. Plasma coenzyme Q(10) concentrations were determined initially and at each study visit. Parents reported adverse events and study drug evaluations using standardized forms. Most of the 16 children who completed this study tolerated high-dose coenzyme Q(10) well. Uncooperative behavior resulted in premature withdrawal of two participants, and may have been treatment-related. Pre- and posttreatment laboratory test changes were considered to be clinically nonsignificant. Study results indicate that high-dose coenzyme Q(10) (10 mg/kg/day) is well-absorbed and well-tolerated by most children with Down syndrome, and appears to provide plasma concentrations which are comparable to previous adult studies administering much higher coenzyme Q(10) dosages.
authors.affiliation: Division of Pathology and Laboratory Medicine, Cincinnati Children's Hospital Medical Center, Ohio 45229, USA. michael.miles@cchmc.org
authors.forename: Michael V
authors.initials: MV
authors.lastname: Miles
authors.forename: Bonnie J
authors.initials: BJ
authors.lastname: Patterson
authors.forename: Mark B
authors.initials: MB
authors.lastname: Schapiro
authors.forename: Francis J
authors.initials: FJ
authors.lastname: Hickey
authors.forename: Melinda
authors.initials: M
authors.lastname: Chalfonte-Evans
authors.forename: Paul S
authors.initials: PS
authors.lastname: Horn
authors.forename: Stephanie L
authors.initials: SL
authors.lastname: Hotze
mesh_terms: D000042:Absorption / Q000187:drug effects / Q000502:physiology; D001526:Behavioral Symptoms / Q000097:blood / Q000139:chemically induced; D002626:Chemistry, Pharmaceutical; D002648:Child; D002675:Child, Preschool; D003067:Coenzymes; D004305:Dose-Response Relationship, Drug; D004314:Down Syndrome / Q000097:blood* / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D014451:Ubiquinone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000097:blood
chemical_list: D003067:Coenzymes; D014451:Ubiquinone; C024989:coenzyme Q10