A Randomized, Double-Masked, Placebo-Controlled Clinical Trial of Multivitamin Supplementation for Age-Related Lens Opacities: Clinical Trial of Nutritional Supplements and Age-Related Cataract Report No. 3
Received 30 October 2007; received in revised form 6 December 2007; accepted 4 January 2008.
Objective
To evaluate the effect of a multivitamin/mineral supplement on development or progression of age-related lens opacities.
Design
Randomized, double-masked, single center, placebo-controlled clinical trial.
Participants
One thousand twenty participants, 55 to 75 years old and with early or no cataract, were randomly assigned to a daily tablet of a multivitamin/mineral formulation or a placebo.
Methods
Baseline and annual lens photographs were graded for severity of lens opacities according to a modification of the Age-Related Eye Disease Study system for classifying cataracts.
Main Outcome Measures
The primary outcome was a prespecified increase from baseline in nuclear, cortical, or posterior subcapsular cataract (PSC) opacity grades or cataract surgery. Secondary outcomes included an increase in type-specific opacity grades, cataract surgery, and visual acuity (VA) loss from baseline ≥15 letters.
Results
Participants were observed for an average of 9.0±2.4 years. There was a decrease in total lens events in participants assigned to the multivitamin/mineral formulation compared with those assigned to the placebo (hazard ratio [HR], 0.82; 95% confidence interval [CI], 0.68–0.98; P = 0.03). Nuclear events were significantly less common (HR, 0.66; 95% CI, 0.50–0.88; P = 0.004) and PSC events significantly more common (HR, 2.00; 95% CI, 1.35–2.98; P<0.001) in participants taking the multivitamin/mineral formulation than in those assigned to the placebo. No statistically significant treatment effects were seen for cortical opacities, moderate VA loss, or cataract surgery.
Conclusions
Lens events were less common in participants who took the multivitamin/mineral formulation, but treatment had opposite effects on the development or progression of nuclear and PSC opacities, the 2 most visually important opacity subtypes.
Reprint requests to Giovanni Maraini, MD, Ophthalmology, Università di Parma, via Gramsci 14, 43100 Parma, Italy.
Manuscript no. 2007-1410.
Financial support: National Eye Institute, Bethesda, Maryland (contract no. N01-EY-5-2100).
No conflicting relationship exists for any author. No member of the Study Group has any relationship with Wyeth Consumer Healthcare.
The members of the writing committee of the Study Group (Giovanni Maraini, Co–Principal Investigator, and Sally L. Williams, University of Parma, Parma, Italy; Robert D. Sperduto, Co–Principal Investigator, and Frederick Ferris, National Eye Institute, Bethesda, Maryland; Roy C. Milton and Traci E. Clemons, EMMES Corp., Rockville, Maryland; and Francesco Rosmini and Luigina Ferrigno, Istituto Superiore di Sanità, Roma, Italy) assume responsibility for the overall content and integrity of the article.
ABSTRACT