Group A: vitamin A 15000 IU/d plus vitamin E 3 IU/d Trace group: vitamin A 75 IU/d plus vitamin E 3 IU/d Group A + E: vitamin A 15000 IU/d plus vitamin E 400 IU/d Group E: vitamin A 75 IU/d plus vitamin E 400 IU/d
Primary outcome: visual acuity Secondary outcomes: visual field Losses to follow-up: 11/45 (24%) lutein capsules group
1 participant on lutein and 2 on placebo had impaired liver function tests at one of their 6-week visits; 2 participants had significant intolerance to multivitamin at the start of the study
240 (225) RP participants Age (mean ± SD): control group: 40 (1.0); lutein + vitamin A group: 38 (1.00) control group: men 53%; lutein + vitamin A group: men 47%
Lutein + vitamin A group: 12 mg/d Control tablet + vitamin A group: cornstarch control
4 years
Primary outcome: visual field Secondary outcomes: ERG; visual acuity Losses to follow-up: 15/240 (6%)
1 patient in the control plus vitamin A group died in a motorcycle accident; 2 patients in the lutein plus vitamin A group showed slight elevations of serum liver function levels at year 4