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Ophthalmic Epidemiol. 2016;23(1):32-9. doi: 10.3109/09286586.2015.1130845. Epub 2016 Jan 20.

Folic Acid, Vitamin B6, and Vitamin B12 in Combination and Age-Related Cataract in a Randomized Trial of Women.

Author information

  • 1a Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital , Harvard Medical School , Boston , MA , USA.
  • 2b Department of Biostatistics, Harvard School of Public Health , Boston , MA , USA.
  • 3c Division of Epidemiology and Clinical Applications , National Eye Institute , Bethesda , MD , USA.
  • 4d Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital , Harvard Medical School , Boston , MA , USA.
  • 5e Department of Epidemiology , Harvard School of Public Health , Boston , MA , USA.

Abstract

PURPOSE:

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.

KEYWORDS:

Cataract; Women’s Antioxidant Folic Acid Cardiovascular Study; folic acid; randomized controlled trial; supplements; vitamin B12; vitamin B6

PMID:
26786311
PMCID:
PMC4948058
DOI:
10.3109/09286586.2015.1130845
[PubMed - indexed for MEDLINE]
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