Evidence map›Paper›PMID 19491213›Full record

Trial reportDiabetes2009

Effect of homocysteine-lowering treatment with folic Acid and B vitamins on risk of type 2 diabetes in women: a randomized, controlled trial.

Yiqing Song, Nancy R Cook, Christine M Albert, Martin Van Denburgh, JoAnn E Manson

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00000541 (Women's Antioxidant and Folic Acid Cardiovascular Study), which is not on this map. Cited by 36 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 4 pooled it
4.9field-weighted citation impact, top 5% 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.

NCT00000541 phase2completednot on this map

Women's Antioxidant and Folic Acid Cardiovascular Study (WAFACS)

TypeinterventionalSponsorBrigham and Women's HospitalRan1993 to 2005ConditionsCardiovascular Diseases, Coronary Arteriosclerosis, Coronary Disease, Heart DiseasesArmsdietary supplements, vitamin C, vitamin E, beta-carotene, folic acid/Vitamin B6/Vitamin B12
3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 4 syntheses or guidelines pooled it, 84 citations in OpenAlex.

  1. Pooled it
  2. Homocysteine-lowering interventions for preventing cardiovascular events.The Cochrane database of systematic reviews · 2017
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Effect of Combined Treatment With Folic Acid, Vitamin BJournal of the American Heart Association · 2018
    Trial
  7. Trial
  8. Review
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  11. Review
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  13. Article
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  15. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

Yiqing SongDivision of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA. ysong3@rics.bwh.harvard.edu.
Nancy R Cook
Christine M Albert
Martin Van Denburgh
JoAnn E Manson
Harvard University · USBrigham and Women's Hospital · 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
Magnesium Intake, Gene Variants, and Type 2 DiabetesK01DK078846 · NIDDK · BRIGHAM AND WOMEN'S HOSPITAL · PI SONG, YIQING · 2008 to 2010
$409k
NHLBI NIH HHS HL46959NHLBI NIH HHS R01 HL046959NIDDK NIH HHS K01 DK078846NIDDK NIH HHS K01-DK078846NIDDK NIH HHS L30 DK084809
6 · The paper itself

Abstract

objectiveHomocysteinemia may play an etiologic role in the pathogenesis of type 2 diabetes by promoting oxidative stress, systemic inflammation, and endothelial dysfunction. We investigated whether homocysteine-lowering treatment by B vitamin supplementation prevents the risk of type 2 diabetes. RESEARCH DESIGN AND

methodsThe Women's Antioxidant and Folic Acid Cardiovascular Study (WAFACS), a randomized, double-blind, placebo-controlled trial of 5,442 female health professionals aged > or = 40 years with a history of cardiovascular disease (CVD) or three or more CVD risk factors, included 4,252 women free of diabetes at baseline. Participants were randomly assigned to either an active treatment group (daily intake of a combination pill of 2.5 mg folic acid, 50 mg vitamin B6, and 1 mg vitamin B12) or to the placebo group.

resultsDuring a median follow-up of 7.3 years, 504 women had an incident diagnosis of type 2 diabetes. Overall, there was no significant difference between the active treatment group and the placebo group in diabetes risk (relative risk 0.94 [95% CI 0.79-1.11]; P = 0.46), despite significant lowering of homocysteine levels. Also, there was no evidence for effect modifications by baseline intakes of dietary folate, vitamin B6, and vitamin B12. In a sensitivity analysis, the null result remained for women compliant with their study pills (0.92 [0.76-1.10]; P = 0.36).

conclusionsLowering homocysteine levels by daily supplementation with folic acid and vitamins B6 and B12 did not reduce the risk of developing type 2 diabetes among women at high risk for CVD.

Indexed as

AdultAgedAscorbic Acidbeta CaroteneCardiovascular DiseasesDiabetes Mellitus, Type 2Double-Blind MethodFemaleFolic AcidFollow-Up StudiesHomocysteineHumansMiddle AgedPlacebosProportional Hazards ModelsRisk FactorsAscorbic Acidbeta CaroteneFolic AcidHomocysteinePlacebosVitamin B 12Vitamin B 6Vitamin E

Identifiers

PMID19491213
PMCPMC2712772
OpenAlexW2168810104

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

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.