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Effect of Combined Treatment With Folic Acid, Vitamin B6, and Vitamin B12 on Plasma Biomarkers of Inflammation and Endothelial Dysfunction in Women.
J Am Heart Assoc 2018; 7(11)JA

Abstract

BACKGROUND

The aim of this study was to determine whether reducing plasma homocysteine concentrations with long-term, combined treatment with folic acid, vitamin B6, and vitamin B12 alters plasma biomarkers of inflammation and endothelial dysfunction in women at increased risk of cardiovascular disease.

METHODS AND RESULTS

We conducted a blood substudy of 300 treatment-adherent participants (150 in the active treatment group, 150 in the placebo group) in the WAFACS (Women's Antioxidant and Folic Acid Cardiovascular Study), a randomized, double-blind, placebo-controlled trial testing a daily combination of folic acid (2.5 mg), vitamin B6 (50 mg), vitamin B12 (1 mg), or matching placebo, in cardiovascular disease prevention among women at increased risk of cardiovascular disease. Plasma concentration of 3 biomarkers of inflammation (C-reactive protein, interleukin-6, and fibrinogen) and a biomarker of endothelial dysfunction (intercellular adhesion molecule 1) were measured at baseline and at the end of treatment and follow-up. After 7.3 years of combined treatment with folic acid, vitamin B6, and vitamin B12, homocysteine concentrations were reduced by 18% in the active treatment group as compared with the placebo group (P<0.001). However, there was no difference between treatment groups in change in blood concentration from baseline to follow-up for C-reactive protein (P=0.77), interleukin-6 (P=0.91), intercellular adhesion molecule 1 (P=0.38), or fibrinogen (P=0.68).

CONCLUSIONS

These findings indicate that long-term, combined treatment with folic acid, vitamin B6, and vitamin B12 lowers homocysteine concentrations, but does not alter major biomarkers of vascular inflammation, consistent with the lack of clinical cardiovascular disease benefit in the trial.

CLINICAL TRIAL REGISTRATION

URL: http://www.clinicaltrials.gov. Unique identifier: NCT00000541.

Authors+Show Affiliations

Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital Harvard Medical School, Boston, MA wchristen@rics.bwh.harvard.edu.Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital Harvard Medical School, Boston, MA. Department of Epidemiology, Harvard School of Public Health, Boston, MA.Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital Harvard Medical School, Boston, MA.Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital Harvard Medical School, Boston, MA.Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital Harvard Medical School, Boston, MA. Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital Harvard Medical School, Boston, MA.Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital Harvard Medical School, Boston, MA. Department of Epidemiology, Harvard School of Public Health, Boston, MA.

Pub Type(s)

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

Language

eng

PubMed ID

29776960

Citation

Christen, William G., et al. "Effect of Combined Treatment With Folic Acid, Vitamin B6, and Vitamin B12 On Plasma Biomarkers of Inflammation and Endothelial Dysfunction in Women." Journal of the American Heart Association, vol. 7, no. 11, 2018.
Christen WG, Cook NR, Van Denburgh M, et al. Effect of Combined Treatment With Folic Acid, Vitamin B6, and Vitamin B12 on Plasma Biomarkers of Inflammation and Endothelial Dysfunction in Women. J Am Heart Assoc. 2018;7(11).
Christen, W. G., Cook, N. R., Van Denburgh, M., Zaharris, E., Albert, C. M., & Manson, J. E. (2018). Effect of Combined Treatment With Folic Acid, Vitamin B6, and Vitamin B12 on Plasma Biomarkers of Inflammation and Endothelial Dysfunction in Women. Journal of the American Heart Association, 7(11), doi:10.1161/JAHA.117.008517.
Christen WG, et al. Effect of Combined Treatment With Folic Acid, Vitamin B6, and Vitamin B12 On Plasma Biomarkers of Inflammation and Endothelial Dysfunction in Women. J Am Heart Assoc. 2018 05 18;7(11) PubMed PMID: 29776960.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of Combined Treatment With Folic Acid, Vitamin B6, and Vitamin B12 on Plasma Biomarkers of Inflammation and Endothelial Dysfunction in Women. AU - Christen,William G, AU - Cook,Nancy R, AU - Van Denburgh,Martin, AU - Zaharris,Elaine, AU - Albert,Christine M, AU - Manson,JoAnn E, Y1 - 2018/05/18/ PY - 2018/5/20/entrez PY - 2018/5/20/pubmed PY - 2019/11/8/medline KW - B vitamins KW - biomarkers KW - cardiovascular disease KW - endothelial dysfunction KW - inflammation KW - randomized trial JF - Journal of the American Heart Association JO - J Am Heart Assoc VL - 7 IS - 11 N2 - BACKGROUND: The aim of this study was to determine whether reducing plasma homocysteine concentrations with long-term, combined treatment with folic acid, vitamin B6, and vitamin B12 alters plasma biomarkers of inflammation and endothelial dysfunction in women at increased risk of cardiovascular disease. METHODS AND RESULTS: We conducted a blood substudy of 300 treatment-adherent participants (150 in the active treatment group, 150 in the placebo group) in the WAFACS (Women's Antioxidant and Folic Acid Cardiovascular Study), a randomized, double-blind, placebo-controlled trial testing a daily combination of folic acid (2.5 mg), vitamin B6 (50 mg), vitamin B12 (1 mg), or matching placebo, in cardiovascular disease prevention among women at increased risk of cardiovascular disease. Plasma concentration of 3 biomarkers of inflammation (C-reactive protein, interleukin-6, and fibrinogen) and a biomarker of endothelial dysfunction (intercellular adhesion molecule 1) were measured at baseline and at the end of treatment and follow-up. After 7.3 years of combined treatment with folic acid, vitamin B6, and vitamin B12, homocysteine concentrations were reduced by 18% in the active treatment group as compared with the placebo group (P<0.001). However, there was no difference between treatment groups in change in blood concentration from baseline to follow-up for C-reactive protein (P=0.77), interleukin-6 (P=0.91), intercellular adhesion molecule 1 (P=0.38), or fibrinogen (P=0.68). CONCLUSIONS: These findings indicate that long-term, combined treatment with folic acid, vitamin B6, and vitamin B12 lowers homocysteine concentrations, but does not alter major biomarkers of vascular inflammation, consistent with the lack of clinical cardiovascular disease benefit in the trial. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00000541. SN - 2047-9980 UR - https://www.unboundmedicine.com/medline/citation/29776960/Effect_of_Combined_Treatment_With_Folic_Acid_Vitamin_B6_and_Vitamin_B12_on_Plasma_Biomarkers_of_Inflammation_and_Endothelial_Dysfunction_in_Women_ L2 - http://www.ahajournals.org/doi/full/10.1161/JAHA.117.008517?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -