. 2013 Dec 13;54(14):ORSF42–ORSF47. doi: 10.1167/iovs13-12914

Table.

Randomized Controlled Clinical Trials for Age-Related Cataract and AMD

Study	Participants	Nutrients Evaluated	Study Results
Randomized, double-masked, placebo-controlled cataract trials
Linxian Cataract Trial¹⁰ (China) Follow-up: 5–6 y	Study I: n = 2,141 Study II: n = 3,249 (ages 45–75)	I: Multivitamin/mineral II: Retinal/zinc, riboflavin/niacin, vitamin C/molybdenum, vitamin E/beta-carotene	I: decrease by 36% in 65–74 y for nuclear cataract progression II: decrease by 44% in 65–74 y nuclear cataract for riboflavin/niacin Increased risk of posterior subcapsular cataract
Physicians' Health Study¹⁵ Follow-up: 8 y	11,545 male physcians, ≥50 y	Vitamin E (440 IU every other day)/vitamin C (500 mg daily)	Vitamin E: HR:0.99 95% CI, 0.88–1.11 Vitamin C: HR 1.02 95% CI, 0.91–1.14 for incident cataract
Physicians' Health Study¹⁹ Follow-up: 12 y	22,071 male physicians, ≥50 y	Beta-carotene (50 mg every other day)	RR 1.00, 95% CI, 0.91–1.09 for incident cataract RR 1.00, 95% CI, 0.89–1.12 for cataract surgery
Women's Health Study¹²	39,876 female health professionals ≥45 y	Vitamin E (600 IU every other day)	RR 0.96, 95% CI, 0.88–1.04 for incident cataract
Follow-up: 9.7 y	39,876 female health professionals ≥45 y	Vitamin E (600 IU every other day)	RR 0.96, 95% CI, 0.88–1.04 for incident cataract
Age-Related Eye Disease Study (AREDS)¹⁷	4,629 men and women 55–80 y	Daily vitamins C (500 mg), E (400 IU), beta-carotene (15 mg), zinc (80 mg), copper (2 mg, AREDS formulation)	OR 0.97, 99% CI, 0.84–1.11 (P = 0.55) for any incident cataract event
Follow-up: 6.3 y	4,629 men and women 55–80 y
Age-Related Eye Disease Study 2 (AREDS2)¹⁸	3,159 men and women 50–80 y	Lutein 10 mg and zeaxanthin 2 mg with the AREDS formulation	HR 0.95 95% CI, 0.83–1.09
Follow-up: 4.7 y	3,159 men and women 50–80 y	Lutein 10 mg and zeaxanthin 2 mg with the AREDS formulation	HR 0.95 95% CI, 0.83–1.09
Italian-American Clinical Trial of Nutritional Supplements (CNTS)¹⁴ (Italy) Follow-up: 9 y	1,020 men and women 55–75 y	Multivitamin/mineral formulation: (Centrum; Lederle Laboratory, Inc., Pearl River, NY)	HR 0.82 95% CI, 0.68–0.98 (P = 0.03) for incident cataract
			HR 0.66 95% CI, 0.50–0.88, (P = 0.004) for incident nuclear cataract
			HR 2.00 95% CI, 1.35–2.98, (P = 0.001) for incident posterior subcapsular cataract
Randomized, double-masked, placebo-controlled age-related macular degeneration trials
Randomized trial of Zinc⁴¹	151 with early AMD, 42–89 y	Zinc sulfate (100 mg); equivalent to 80 mg of elemental zinc	Visual acuity change (final compared to baseline vision) was significantly less likely to deteriorate in the zinc treated group (P < 0.05)
Follow-up: 12–24 m	151 with early AMD, 42–89 y
Age-Related Eye Disease Study (AREDS)¹⁷	3,640 men and women 55–80 y	Daily vitamins C (500 mg), E (400 IU), beta-carotene (15 mg), zinc (80 mg), copper (2 mg, AREDS formulation)	OR 0.72, 99% CI, 0.52–0.98 (P = 0.002) for progression to advanced AMD
Follow-up: 6.3 y	3,640 men and women 55–80 y
Age-Related Eye Disease Study 2 (AREDS2)¹⁸	4,203 men and women 50–85 y	Lutein 10 mg and zeaxanthin 2 mg and omega-3 fatty acids (DHA and EPA 1 g) along with the AREDS formulation	Primary analyses using the entire study population did result in statistically significant differences. Main effects analyses of lutein/zeaxanthin vs. NO lutein/zeaxanthin: HR: 0.90, 95% CI, 0.82–0.99, (P = 0.04)
Follow-up: 5.0 y	4,203 men and women 50–85 y
Women's Antioxidant and Folic Acid Cardiovascular Study	5,205 female health care professionals at risk or with preexisting cardiovascular disease ≥ 40 y	Folic acid 2.5 mg, pyridoxine hydrochloride or B₆ 50 mg, cyancobalamin or B₁₂ 1 mg	RR 0.66, 95% CI, 0.47–0.93 (P = 0.02) for development of advanced AMD
Follow-up: 7.3 y