May 2007
Volume 48, Issue 13
ARVO Annual Meeting Abstract  |   May 2007
Folic Acid Plus B-Vitamins and Age-Related Macular Degeneration in a Randomized Trial in Women
Author Affiliations & Notes
  • W. G. Christen
    Medicine, Brigham & Womens Hosp/Harvard, Boston, Massachusetts
  • R. J. Glynn
    Medicine, Brigham & Womens Hosp/Harvard, Boston, Massachusetts
  • E. Y. Chew
    National Eye Institute, Bethesda, Maryland
  • J. E. Manson
    Medicine, Brigham & Womens Hosp/Harvard, Boston, Massachusetts
  • Footnotes
    Commercial Relationships W.G. Christen, None; R.J. Glynn, None; E.Y. Chew, None; J.E. Manson, None.
  • Footnotes
    Support NIH Grants HL46959 and EY06633. B-vitamin pills and placebos were provided by BASF.
Investigative Ophthalmology & Visual Science May 2007, Vol.48, 1152. doi:
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      W. G. Christen, R. J. Glynn, E. Y. Chew, J. E. Manson; Folic Acid Plus B-Vitamins and Age-Related Macular Degeneration in a Randomized Trial in Women. Invest. Ophthalmol. Vis. Sci. 2007;48(13):1152.

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      © ARVO (1962-2015); The Authors (2016-present)

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Purpose:: To examine incidence of age-related macular degeneration (AMD) in a randomized trial of folic acid/vitamin B6/vitamin B12.

Methods:: The Women's Antioxidant and Folic Acid Cardiovascular Study was a randomized, double-blind, placebo-controlled trial of antioxidant vitamins and a folic acid/vitamin B6/vitamin B12 combination in the prevention of cardiovascular (CVD) events among female health professionals aged 40 years or older with preexisting CVD or 3 or more CVD risk factors. A total of 8,171 women were randomized to vitamin E, vitamin C, beta carotene, or placebos. Of these, 5,442 women were also subsequently randomized to folic acid (2.5 mg/d), vitamin B6 (50 mg/d), and vitamin B12 (1 mg/d), or placebo; 5,205 of these women did not have a diagnosis of AMD at baseline and were included in this analysis. Main outcome measures were confirmed AMD, defined as a self-report supported by medical record evidence of an initial diagnosis subsequent to randomization, and AMD with vision loss, defined as confirmed AMD with vision to 20/30 or worse attributable to this condition.

Results:: During an average of 7.3 years of treatment and follow-up, a total of 137 cases of AMD were documented, including 69 cases responsible for vision loss to 20/30 or worse. For the endpoint of confirmed AMD, there were 55 cases in the folic acid/B6/B12 group and 82 in the placebo group (relative risk [RR], 0.66; 95% confidence interval [CI], 0.47-0.93; p=0.02). For AMD with vision loss, there were 26 cases in the folic acid/B6/B12 group and 43 in the placebo group (RR, 0.60; 95% CI, 0.37-0.98; p=0.04).

Conclusions:: These randomized trial data from a large cohort of women with CVD indicate that seven years of daily supplementation with folic acid/B6/B12 may reduce the risk of AMD.

Clinical Trial:: NCT00000161

Keywords: age-related macular degeneration • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • nutritional factors 

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