Evidence map›Paper›PMID 26786311›Full record

Trial reportOphthalmic epidemiology2016

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

William G Christen, Robert J Glynn, Emily Y Chew, Christine M Albert, JoAnn E Manson

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Ophthalmic epidemiology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
2.4field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 20 citations in OpenAlex.

  1. B Vitamins and Ocular Health.Clinical ophthalmology (Auckland, N.Z.) · 2026
    Review
  2. Article
  3. Review
  4. Review
  5. Article
  6. Article
  7. Review
  8. Review
  9. Article
  10. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

William G Christena Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital , Harvard Medical School , Boston , MA , USA.
Robert J Glynna Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital , Harvard Medical School , Boston , MA , USA.
Emily Y Chewc Division of Epidemiology and Clinical Applications , National Eye Institute , Bethesda , MD , USA.
Christine M Alberta Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital , Harvard Medical School , Boston , MA , USA.
JoAnn E Mansona Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital , Harvard Medical School , Boston , MA , USA.
Harvard University · USNational Eye Institute · US

Funding

TRIAL OF ANTIOXIDANT THERAPY OF CVD IN WOMENR01HL046959 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI MANSON, JOANN ELISABETH · 1993 to 2005
$3.6M
RANDOMIZED TRIALS OF VITAMIN SUPPLEMENTS AND EYE DISEASER01EY006633 · NEI · BRIGHAM AND WOMEN'S HOSPITAL · PI CHRISTEN, WILLIAM G · 1986 to 2002
$876k
Age-Related Eye Disease Follow-up Study (AREDS) Follow-up StudyZIAEY000489 · NEI · NATIONAL EYE INSTITUTE · PI CHEW, EMILY Y · 2009 to 2025
$639k
NEI NIH HHS EY06633NHLBI NIH HHS HL46959NHLBI NIH HHS R01 HL046959
6 · The paper itself

Abstract

purposeTo examine the incidence of cataract and cataract extraction in a trial of folic acid and vitamins B6 and B12.

methodsIn 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.

resultsDuring 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).

conclusionsIn 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.

Indexed as

AdultAgedCardiovascular DiseasesCataractCataract ExtractionDouble-Blind MethodDrug CombinationsFemaleFolic AcidHealth PersonnelHumansIncidenceMiddle AgedRisk FactorsVitamin B 12Vitamin B 6Drug CombinationsFolic AcidVitamin B 12Vitamin B 6Vitamin B ComplexCataractfolic acidrandomized controlled trialsupplementsvitamin B12vitamin B6Women’s Antioxidant Folic Acid Cardiovascular Study

Identifiers

PMID26786311
PMCPMC4948058
OpenAlexW2283771758

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.