Clinical trial of lutein in patients with retinitis pigmentosa receiving vitamin A.
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.
Berson
Eliot L
EL
Berman-Gund Laboratory for Study of Retinal Degenerations, Harvard Medical School, Massachusetts Eye and Ear Infirmary, Boston, MA 02114, USA.
Rosner
Bernard
B
Sandberg
Michael A
MA
Weigel-DiFranco
Carol
C
Brockhurst
Robert J
RJ
Hayes
K C
KC
Johnson
Elizabeth J
EJ
Anderson
Ellen J
EJ
Johnson
Chris A
CA
Gaudio
Alexander R
AR
Willett
Walter C
WC
Schaefer
Ernst J
EJ
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
D013607:Tablets; D014801:Vitamin A; D014975:Lutein
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