title: Oral zinc sulphate supplementation for six months in SCA2 patients: a randomized, double-blind, placebo-controlled trial.
abstract: Cuban patients with Spinocerebellar Ataxia type 2 (SCA2) have reduced concentrations of zinc in serum and cerebrospinal fluid (CSF). To assess the effect and safety of zinc supplementation, 36 Cuban SCA2 patients were randomly assigned to receive daily either 50 mg ZnSO(4) or placebo, together with neurorehabilitation therapy in a randomized, double-blind, placebo-controlled clinical trial during 6 months. Outcome measures included the changes of zinc levels in CSF and serum, ataxia score, oxidative stress and saccadic eye movements. At the end of the study, the Zinc-treated group showed: (i) a significant increase of the Zn levels in the CSF, (ii) mild decrease in the ataxia scale subscores for gait, posture, stance and dysdiadochocinesia (iii) reduction of lipid's oxidative damage, and (iv) reduction of saccadic latency when compared with the placebo group. The treatment was safe and well tolerated by all subjects. This study demonstrated the efficacy and safety of Zn supplementation, combined with neurorehabilitation for SCA2 patients and therefore it may encourage further studies on the clinical effect of zinc supplementation in SCA2 based in the conduction of future clinical trials with higher number of subjects.
authors.affiliation: Centro Para la Investigación y Rehabilitación de las Ataxias Hereditarias, Carretera Central Km 5 ½ Reparto Edecio Pérez, 80100 Holguín, Cuba. cirahsca2@cristal.hlg.sld.cu
authors.forename: Luis
authors.initials: L
authors.lastname: Velázquez-Pérez
authors.forename: Jorge
authors.initials: J
authors.lastname: Rodríguez-Chanfrau
authors.forename: Julio Cesar
authors.initials: JC
authors.lastname: García-Rodríguez
authors.forename: Gilberto
authors.initials: G
authors.lastname: Sánchez-Cruz
authors.forename: Raúl
authors.initials: R
authors.lastname: Aguilera-Rodríguez
authors.forename: Roberto
authors.initials: R
authors.lastname: Rodríguez-Labrada
authors.forename: Julio Cesar
authors.initials: JC
authors.lastname: Rodríguez-Díaz
authors.forename: Nalia
authors.initials: N
authors.lastname: Canales-Ochoa
authors.forename: Dennis Almaguer
authors.initials: DA
authors.lastname: Gotay
authors.forename: Luis E
authors.initials: LE
authors.lastname: Almaguer Mederos
authors.forename: José M
authors.initials: JM
authors.lastname: Laffita Mesa
authors.forename: Marlene
authors.initials: M
authors.lastname: Porto-Verdecia
authors.forename: Consuelo González
authors.initials: CG
authors.lastname: Triana
authors.forename: Noemí Rodríguez
authors.initials: NR
authors.lastname: Pupo
authors.forename: Idania Hidalgo
authors.initials: IH
authors.lastname: Batista
authors.forename: Orestes D
authors.initials: OD
authors.lastname: López-Hernandez
authors.forename: Iverlis Díaz
authors.initials: ID
authors.lastname: Polanco
authors.forename: Arelis Jayme
authors.initials: AJ
authors.lastname: Novas
mesh_terms: D000293:Adolescent; D000328:Adult; D002374:Catalase / Q000097:blood; D003462:Cuba; D019587:Dietary Supplements; D004311:Double-Blind Method; D006801:Humans; D008315:Malondialdehyde / Q000097:blood; D008875:Middle Aged; D010919:Placebos; D012438:Saccades / Q000502:physiology; D020754:Spinocerebellar Ataxias / Q000188:drug therapy* / Q000503:physiopathology / Q000534:rehabilitation; D013482:Superoxide Dismutase / Q000097:blood; D016896:Treatment Outcome; D055815:Young Adult; D015032:Zinc / Q000097:blood; D019287:Zinc Sulfate / Q000008:administration & dosage* / Q000627:therapeutic use*
chemical_list: D010919:Placebos; D008315:Malondialdehyde; D019287:Zinc Sulfate; D002374:Catalase; D013482:Superoxide Dismutase; D015032:Zinc