title: Clinical trial of lutein in patients with retinitis pigmentosa receiving vitamin A.
abstract: OBJECTIVE
  To determine whether lutein supplementation will slow visual function decline in patients with retinitis pigmentosa receiving vitamin A.
  
  
  METHODS
  Randomized, controlled, double-masked trial of 225 nonsmoking patients, aged 18 to 60 years, evaluated over a 4-year interval. Patients received 12 mg of lutein or a control tablet daily. All were given 15,000 IU/d of vitamin A palmitate. Randomization took into account genetic type and baseline serum lutein level.
  
  
  METHODS
  The primary outcome was the total point score for the Humphrey Field Analyzer (HFA) 30-2 program; prespecified secondary outcomes were the total point scores for the 60-4 program and for the 30-2 and 60-4 programs combined, 30-Hz electroretinogram amplitude, and Early Treatment Diabetic Retinopathy Study acuity.
  
  
  RESULTS
  No significant difference in rate of decline was found between the lutein plus vitamin A and control plus vitamin A groups over a 4-year interval for the HFA 30-2 program. For the HFA 60-4 program, a decrease in mean rate of sensitivity loss was observed in the lutein plus vitamin A group (P = .05). Mean decline with the 60-4 program was slower among those with the highest serum lutein level or with the highest increase in macular pigment optical density at follow-up (P = .01 and P = .006, respectively). Those with the highest increase in macular pigment optical density also had the slowest decline in HFA 30-2 and 60-4 combined field sensitivity (P = .005). No significant toxic effects of lutein supplementation were observed.
  
  
  CONCLUSIONS
  Lutein supplementation of 12 mg/d slowed loss of midperipheral visual field on average among nonsmoking adults with retinitis pigmentosa taking vitamin A. Application to Clinical Practice Data are presented that support use of 12 mg/d of lutein to slow visual field loss among nonsmoking adults with retinitis pigmentosa taking vitamin A.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT00346333.
authors.affiliation: Berman-Gund Laboratory for Study of Retinal Degenerations, Harvard Medical School, Massachusetts Eye and Ear Infirmary, Boston, MA 02114, USA.
authors.forename: Eliot L
authors.initials: EL
authors.lastname: Berson
authors.forename: Bernard
authors.initials: B
authors.lastname: Rosner
authors.forename: Michael A
authors.initials: MA
authors.lastname: Sandberg
authors.forename: Carol
authors.initials: C
authors.lastname: Weigel-DiFranco
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Brockhurst
authors.forename: K C
authors.initials: KC
authors.lastname: Hayes
authors.forename: Elizabeth J
authors.initials: EJ
authors.lastname: Johnson
authors.forename: Ellen J
authors.initials: EJ
authors.lastname: Anderson
authors.forename: Chris A
authors.initials: CA
authors.lastname: Johnson
authors.forename: Alexander R
authors.initials: AR
authors.lastname: Gaudio
authors.forename: Walter C
authors.initials: WC
authors.lastname: Willett
authors.forename: Ernst J
authors.initials: EJ
authors.lastname: Schaefer
mesh_terms: D000293:Adolescent; D000328:Adult; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D014975:Lutein / Q000008:administration & dosage* / Q000097:blood; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D012174:Retinitis Pigmentosa / Q000188:drug therapy* / Q000503:physiopathology; D011795:Surveys and Questionnaires; D013607:Tablets; D014786:Vision Disorders / Q000188:drug therapy* / Q000503:physiopathology; D014792:Visual Acuity / Q000502:physiology; D058609:Visual Field Tests; D014794:Visual Fields / Q000502:physiology*; D014801:Vitamin A / Q000008:administration & dosage* / Q000097:blood; D055815:Young Adult
chemical_list: D013607:Tablets; D014801:Vitamin A; D014975:Lutein
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