title: Folic Acid, Vitamin B6, and Vitamin B12 in Combination and Age-Related Cataract in a Randomized Trial of Women.
abstract: OBJECTIVE
  To examine the incidence of cataract and cataract extraction in a trial of folic acid and vitamins B6 and B12.
  
  
  METHODS
  In a randomized, double-masked, placebo-controlled trial, 5442 female health professionals aged 40 years or older with preexisting cardiovascular disease (CVD) or three or more CVD risk factors were randomly assigned to receive a combination of folic acid (2.5 mg/day), vitamin B6 (50 mg/day), and vitamin B12 (1 mg/day), or placebo. A total of 3925 of these women did not have a diagnosis of cataract at baseline and were included in this analysis. The primary endpoint was age-related cataract, defined as an incident age-related lens opacity, responsible for a reduction in best-corrected visual acuity to 20/30 or worse, based on self-report confirmed by medical record review. Extraction of incident age-related cataract was a secondary endpoint of the trial.
  
  
  RESULTS
  During an average of 7.3 years of treatment and follow-up, 408 cataracts and 275 cataract extractions were documented. There were 215 cataracts in the combination treatment group and 193 in the placebo group (hazard ratio, HR, 1.10, 95% confidence interval, CI, 0.90-1.33; p = 0.36). For the secondary endpoint of cataract extraction, there were 155 in the combination treatment group and 120 in the placebo group (HR 1.28, 95% CI 1.01-1.63; p = 0.04).
  
  
  CONCLUSIONS
  In this large-scale randomized trial of women at high risk of CVD, daily supplementation with a combination of folic acid, vitamin B6, and vitamin B12 had no significant effect on cataract, but may have increased the risk of cataract extraction.
authors.affiliation: a Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital , Harvard Medical School , Boston , MA , USA.
authors.forename: William G
authors.initials: WG
authors.lastname: Christen
authors.affiliation: a Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital , Harvard Medical School , Boston , MA , USA.|b Department of Biostatistics, Harvard School of Public Health , Boston , MA , USA.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Glynn
authors.affiliation: c Division of Epidemiology and Clinical Applications , National Eye Institute , Bethesda , MD , USA.
authors.forename: Emily Y
authors.initials: EY
authors.lastname: Chew
authors.affiliation: a Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital , Harvard Medical School , Boston , MA , USA.|d Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital , Harvard Medical School , Boston , MA , USA.
authors.forename: Christine M
authors.initials: CM
authors.lastname: Albert
authors.affiliation: a Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital , Harvard Medical School , Boston , MA , USA.|e Department of Epidemiology , Harvard School of Public Health , Boston , MA , USA.
authors.forename: JoAnn E
authors.initials: JE
authors.lastname: Manson
mesh_terms: D000328:Adult; D000368:Aged; D002318:Cardiovascular Diseases / Q000453:epidemiology / Q000517:prevention & control; D002386:Cataract / Q000453:epidemiology*; D002387:Cataract Extraction / Q000706:statistics & numerical data*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005492:Folic Acid / Q000008:administration & dosage*; D006282:Health Personnel; D006801:Humans; D015994:Incidence; D008875:Middle Aged; D012307:Risk Factors; D014805:Vitamin B 12 / Q000008:administration & dosage*; D025101:Vitamin B 6 / Q000008:administration & dosage*; D014803:Vitamin B Complex / Q000008:administration & dosage*
chemical_list: D004338:Drug Combinations; D014803:Vitamin B Complex; D025101:Vitamin B 6; D005492:Folic Acid; D014805:Vitamin B 12
keywords: Cataract; Women’s Antioxidant Folic Acid Cardiovascular Study; folic acid; randomized controlled trial; supplements; vitamin B12; vitamin B6