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Folic Acid, Vitamin B6, and Vitamin B12 in Combination and Age-Related Cataract in a Randomized Trial of Women.
Ophthalmic Epidemiol 2016; 23(1):32-9OE

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+Show Affiliations

a Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital , Harvard Medical School , Boston , MA , USA.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.c Division of Epidemiology and Clinical Applications , National Eye Institute , Bethesda , MD , USA.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.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.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

26786311

Citation

Christen, William G., et al. "Folic Acid, Vitamin B6, and Vitamin B12 in Combination and Age-Related Cataract in a Randomized Trial of Women." Ophthalmic Epidemiology, vol. 23, no. 1, 2016, pp. 32-9.
Christen WG, Glynn RJ, Chew EY, et al. Folic Acid, Vitamin B6, and Vitamin B12 in Combination and Age-Related Cataract in a Randomized Trial of Women. Ophthalmic Epidemiol. 2016;23(1):32-9.
Christen, W. G., Glynn, R. J., Chew, E. Y., Albert, C. M., & Manson, J. E. (2016). Folic Acid, Vitamin B6, and Vitamin B12 in Combination and Age-Related Cataract in a Randomized Trial of Women. Ophthalmic Epidemiology, 23(1), pp. 32-9. doi:10.3109/09286586.2015.1130845.
Christen WG, et al. Folic Acid, Vitamin B6, and Vitamin B12 in Combination and Age-Related Cataract in a Randomized Trial of Women. Ophthalmic Epidemiol. 2016;23(1):32-9. PubMed PMID: 26786311.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Folic Acid, Vitamin B6, and Vitamin B12 in Combination and Age-Related Cataract in a Randomized Trial of Women. AU - Christen,William G, AU - Glynn,Robert J, AU - Chew,Emily Y, AU - Albert,Christine M, AU - Manson,JoAnn E, Y1 - 2016/01/20/ PY - 2016/1/21/entrez PY - 2016/1/21/pubmed PY - 2016/8/25/medline KW - Cataract KW - Women’s Antioxidant Folic Acid Cardiovascular Study KW - folic acid KW - randomized controlled trial KW - supplements KW - vitamin B12 KW - vitamin B6 SP - 32 EP - 9 JF - Ophthalmic epidemiology JO - Ophthalmic Epidemiol VL - 23 IS - 1 N2 - 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. SN - 1744-5086 UR - https://www.unboundmedicine.com/medline/citation/26786311/Folic_Acid_Vitamin_B6_and_Vitamin_B12_in_Combination_and_Age_Related_Cataract_in_a_Randomized_Trial_of_Women_ L2 - http://www.tandfonline.com/doi/full/10.3109/09286586.2015.1130845 DB - PRIME DP - Unbound Medicine ER -