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

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.

• Authors: William G Christen, Robert J Glynn, Emily Y Chew, Christine M Albert, JoAnn E Manson
• Journal: Ophthalmic epidemiology (Ophthalmic Epidemiol) Vol. 23 Issue 1 Pg. 32-9 ( 2016) ISSN: 1744-5086 [Electronic] England
• PMID: 26786311 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural)

Chemical References

• Drug Combinations
• Vitamin B Complex
• Vitamin B 6
• Folic Acid
• Vitamin B 12

Topics

• Adult
• Aged
• Cardiovascular Diseases (epidemiology, prevention & control)
• Cataract (epidemiology)
• Cataract Extraction (statistics & numerical data)
• Double-Blind Method
• Drug Combinations
• Female
• Folic Acid (administration & dosage)
• Health Personnel
• Humans
• Incidence
• Middle Aged
• Risk Factors
• Vitamin B 12 (administration & dosage)
• Vitamin B 6 (administration & dosage)
• Vitamin B Complex (administration & dosage)