High-Dose B Vitamin Supplementation and Progression of Subclinical Atherosclerosis A Randomized Controlled Trial
Background and Purpose— Although plasma total homocysteine (tHcy) levels are associated with cardiovascular disease, it remains unclear whether homocysteine is a cause or a marker of atherosclerotic vascular disease. We determined whether reduction of tHcy levels with B vitamin supplementation reduc...
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| Published in | Stroke (1970) Vol. 40; no. 3; pp. 730 - 736 |
|---|---|
| Main Authors | , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Hagerstown, MD
Lippincott Williams & Wilkins
01.03.2009
|
| Subjects | |
| Online Access | Get full text |
| ISSN | 0039-2499 1524-4628 1524-4628 |
| DOI | 10.1161/STROKEAHA.108.526798 |
Cover
| Abstract | Background and Purpose—
Although plasma total homocysteine (tHcy) levels are associated with cardiovascular disease, it remains unclear whether homocysteine is a cause or a marker of atherosclerotic vascular disease. We determined whether reduction of tHcy levels with B vitamin supplementation reduces subclinical atherosclerosis progression.
Methods—
In this double-blind clinical trial, 506 participants 40 to 89 years of age with an initial tHcy >8.5 μmol/L without diabetes and cardiovascular disease were randomized to high-dose B vitamin supplementation (5 mg folic acid+0.4 mg vitamin B
12
+50 mg vitamin B
6
) or matching placebo for 3.1 years. Subclinical atherosclerosis progression across 3 vascular beds was assessed using high-resolution B-mode ultrasonography to measure carotid artery intima media thickness (primary outcome) and multidetector spiral CT to measure aortic and coronary artery calcium (secondary outcome).
Results—
Although the overall carotid artery intima media thickness progression rate was lower with B vitamin supplementation than with placebo, statistically significant between-group differences were not found (
P
=0.31). However, among subjects with baseline tHcy ≥9.1 μmol/L, those randomized to B vitamin supplementation had a statistically significant lower average rate of carotid artery intima media thickness progression compared with placebo (
P
=0.02); among subjects with a baseline tHcy <9.1 μmol/L, there was no significant treatment effect (probability value for treatment interaction=0.02). B vitamin supplementation had no effect on progression of aortic or coronary artery calcification overall or within subgroups.
Conclusion—
High-dose B vitamin supplementation significantly reduces progression of early-stage subclinical atherosclerosis (carotid artery intima media thickness) in well-nourished healthy B vitamin “replete” individuals at low risk for cardiovascular disease with a fasting tHcy ≥9.1 μmol/L. |
|---|---|
| AbstractList | Although plasma total homocysteine (tHcy) levels are associated with cardiovascular disease, it remains unclear whether homocysteine is a cause or a marker of atherosclerotic vascular disease. We determined whether reduction of tHcy levels with B vitamin supplementation reduces subclinical atherosclerosis progression.
In this double-blind clinical trial, 506 participants 40 to 89 years of age with an initial tHcy >8.5 micromol/L without diabetes and cardiovascular disease were randomized to high-dose B vitamin supplementation (5 mg folic acid+0.4 mg vitamin B(12)+50 mg vitamin B(6)) or matching placebo for 3.1 years. Subclinical atherosclerosis progression across 3 vascular beds was assessed using high-resolution B-mode ultrasonography to measure carotid artery intima media thickness (primary outcome) and multidetector spiral CT to measure aortic and coronary artery calcium (secondary outcome).
Although the overall carotid artery intima media thickness progression rate was lower with B vitamin supplementation than with placebo, statistically significant between-group differences were not found (P=0.31). However, among subjects with baseline tHcy >or=9.1 micromol/L, those randomized to B vitamin supplementation had a statistically significant lower average rate of carotid artery intima media thickness progression compared with placebo (P=0.02); among subjects with a baseline tHcy <9.1 micromol/L, there was no significant treatment effect (probability value for treatment interaction=0.02). B vitamin supplementation had no effect on progression of aortic or coronary artery calcification overall or within subgroups.
High-dose B vitamin supplementation significantly reduces progression of early-stage subclinical atherosclerosis (carotid artery intima media thickness) in well-nourished healthy B vitamin "replete" individuals at low risk for cardiovascular disease with a fasting tHcy >or=9.1 micromol/L. Although plasma total homocysteine (tHcy) levels are associated with cardiovascular disease, it remains unclear whether homocysteine is a cause or a marker of atherosclerotic vascular disease. We determined whether reduction of tHcy levels with B vitamin supplementation reduces subclinical atherosclerosis progression.BACKGROUND AND PURPOSEAlthough plasma total homocysteine (tHcy) levels are associated with cardiovascular disease, it remains unclear whether homocysteine is a cause or a marker of atherosclerotic vascular disease. We determined whether reduction of tHcy levels with B vitamin supplementation reduces subclinical atherosclerosis progression.In this double-blind clinical trial, 506 participants 40 to 89 years of age with an initial tHcy >8.5 micromol/L without diabetes and cardiovascular disease were randomized to high-dose B vitamin supplementation (5 mg folic acid+0.4 mg vitamin B(12)+50 mg vitamin B(6)) or matching placebo for 3.1 years. Subclinical atherosclerosis progression across 3 vascular beds was assessed using high-resolution B-mode ultrasonography to measure carotid artery intima media thickness (primary outcome) and multidetector spiral CT to measure aortic and coronary artery calcium (secondary outcome).METHODSIn this double-blind clinical trial, 506 participants 40 to 89 years of age with an initial tHcy >8.5 micromol/L without diabetes and cardiovascular disease were randomized to high-dose B vitamin supplementation (5 mg folic acid+0.4 mg vitamin B(12)+50 mg vitamin B(6)) or matching placebo for 3.1 years. Subclinical atherosclerosis progression across 3 vascular beds was assessed using high-resolution B-mode ultrasonography to measure carotid artery intima media thickness (primary outcome) and multidetector spiral CT to measure aortic and coronary artery calcium (secondary outcome).Although the overall carotid artery intima media thickness progression rate was lower with B vitamin supplementation than with placebo, statistically significant between-group differences were not found (P=0.31). However, among subjects with baseline tHcy >or=9.1 micromol/L, those randomized to B vitamin supplementation had a statistically significant lower average rate of carotid artery intima media thickness progression compared with placebo (P=0.02); among subjects with a baseline tHcy <9.1 micromol/L, there was no significant treatment effect (probability value for treatment interaction=0.02). B vitamin supplementation had no effect on progression of aortic or coronary artery calcification overall or within subgroups.RESULTSAlthough the overall carotid artery intima media thickness progression rate was lower with B vitamin supplementation than with placebo, statistically significant between-group differences were not found (P=0.31). However, among subjects with baseline tHcy >or=9.1 micromol/L, those randomized to B vitamin supplementation had a statistically significant lower average rate of carotid artery intima media thickness progression compared with placebo (P=0.02); among subjects with a baseline tHcy <9.1 micromol/L, there was no significant treatment effect (probability value for treatment interaction=0.02). B vitamin supplementation had no effect on progression of aortic or coronary artery calcification overall or within subgroups.High-dose B vitamin supplementation significantly reduces progression of early-stage subclinical atherosclerosis (carotid artery intima media thickness) in well-nourished healthy B vitamin "replete" individuals at low risk for cardiovascular disease with a fasting tHcy >or=9.1 micromol/L.CONCLUSIONSHigh-dose B vitamin supplementation significantly reduces progression of early-stage subclinical atherosclerosis (carotid artery intima media thickness) in well-nourished healthy B vitamin "replete" individuals at low risk for cardiovascular disease with a fasting tHcy >or=9.1 micromol/L. Background and Purpose— Although plasma total homocysteine (tHcy) levels are associated with cardiovascular disease, it remains unclear whether homocysteine is a cause or a marker of atherosclerotic vascular disease. We determined whether reduction of tHcy levels with B vitamin supplementation reduces subclinical atherosclerosis progression. Methods— In this double-blind clinical trial, 506 participants 40 to 89 years of age with an initial tHcy >8.5 μmol/L without diabetes and cardiovascular disease were randomized to high-dose B vitamin supplementation (5 mg folic acid+0.4 mg vitamin B 12 +50 mg vitamin B 6 ) or matching placebo for 3.1 years. Subclinical atherosclerosis progression across 3 vascular beds was assessed using high-resolution B-mode ultrasonography to measure carotid artery intima media thickness (primary outcome) and multidetector spiral CT to measure aortic and coronary artery calcium (secondary outcome). Results— Although the overall carotid artery intima media thickness progression rate was lower with B vitamin supplementation than with placebo, statistically significant between-group differences were not found ( P =0.31). However, among subjects with baseline tHcy ≥9.1 μmol/L, those randomized to B vitamin supplementation had a statistically significant lower average rate of carotid artery intima media thickness progression compared with placebo ( P =0.02); among subjects with a baseline tHcy <9.1 μmol/L, there was no significant treatment effect (probability value for treatment interaction=0.02). B vitamin supplementation had no effect on progression of aortic or coronary artery calcification overall or within subgroups. Conclusion— High-dose B vitamin supplementation significantly reduces progression of early-stage subclinical atherosclerosis (carotid artery intima media thickness) in well-nourished healthy B vitamin “replete” individuals at low risk for cardiovascular disease with a fasting tHcy ≥9.1 μmol/L. |
| Author | Detrano, Robert Alaupovic, Petar Liu, Ci-hua Wilcox, Alison G. Dustin, Laurie Mack, Wendy J. Hwang, Juliana Azen, Stanley P. Selzer, Robert H. Liu, Chao-ran Mahrer, Peter R. Hodis, Howard N. Selhub, Jacob |
| AuthorAffiliation | 2 University of Southern California, Keck School of Medicine, Department of Preventive Medicine 1 University of Southern California, Keck School of Medicine, Atherosclerosis Research Unit 6 Harbor-University of California at Los Angeles, Los Angeles, CA 3 University of Southern California, Keck School of Medicine, Department of Medicine 4 University of Southern California, School of Pharmacy, Department of Molecular Pharmacology and Toxicology 7 USDA Human Nutrition Research Center on Aging and Department of Vitamin Metabolism and Aging, Tufts University, Boston, MA 9 University of Southern California, Keck School of Medicine, Department of Radiology 5 Kaiser Permanente Medical Center, Los Angeles, CA 8 Oklahoma Medical Research Foundation, Oklahoma City, OK 10 Jet Propulsion Laboratory, California Institute of Technology, Pasadena, CA |
| AuthorAffiliation_xml | – name: 3 University of Southern California, Keck School of Medicine, Department of Medicine – name: 2 University of Southern California, Keck School of Medicine, Department of Preventive Medicine – name: 8 Oklahoma Medical Research Foundation, Oklahoma City, OK – name: 5 Kaiser Permanente Medical Center, Los Angeles, CA – name: 7 USDA Human Nutrition Research Center on Aging and Department of Vitamin Metabolism and Aging, Tufts University, Boston, MA – name: 1 University of Southern California, Keck School of Medicine, Atherosclerosis Research Unit – name: 9 University of Southern California, Keck School of Medicine, Department of Radiology – name: 10 Jet Propulsion Laboratory, California Institute of Technology, Pasadena, CA – name: 4 University of Southern California, School of Pharmacy, Department of Molecular Pharmacology and Toxicology – name: 6 Harbor-University of California at Los Angeles, Los Angeles, CA |
| Author_xml | – sequence: 1 givenname: Howard N. surname: Hodis fullname: Hodis, Howard N. organization: From the Atherosclerosis Research Unit (H.N.H., W.J.M., L.D., S.P.A., C.-r.L., C.-h.L., J.H., R.H.S.), the Department of Preventive Medicine (H.N.H., W.J.M., L.D., S.P.A.), the Department of Medicine (H.N.H., C.-r.L., C.-h.L.), and the Department of Radiology (A.G.W.), University of Southern California, Keck School of Medicine, Los Angeles, Calif; the Department of Molecular Pharmacology and Toxicology (H.N.H., J.H.), University of Southern California, School of Pharmacy, Los Angeles, Calif; Kaiser – sequence: 2 givenname: Wendy J. surname: Mack fullname: Mack, Wendy J. organization: From the Atherosclerosis Research Unit (H.N.H., W.J.M., L.D., S.P.A., C.-r.L., C.-h.L., J.H., R.H.S.), the Department of Preventive Medicine (H.N.H., W.J.M., L.D., S.P.A.), the Department of Medicine (H.N.H., C.-r.L., C.-h.L.), and the Department of Radiology (A.G.W.), University of Southern California, Keck School of Medicine, Los Angeles, Calif; the Department of Molecular Pharmacology and Toxicology (H.N.H., J.H.), University of Southern California, School of Pharmacy, Los Angeles, Calif; Kaiser – sequence: 3 givenname: Laurie surname: Dustin fullname: Dustin, Laurie organization: From the Atherosclerosis Research Unit (H.N.H., W.J.M., L.D., S.P.A., C.-r.L., C.-h.L., J.H., R.H.S.), the Department of Preventive Medicine (H.N.H., W.J.M., L.D., S.P.A.), the Department of Medicine (H.N.H., C.-r.L., C.-h.L.), and the Department of Radiology (A.G.W.), University of Southern California, Keck School of Medicine, Los Angeles, Calif; the Department of Molecular Pharmacology and Toxicology (H.N.H., J.H.), University of Southern California, School of Pharmacy, Los Angeles, Calif; Kaiser – sequence: 4 givenname: Peter R. surname: Mahrer fullname: Mahrer, Peter R. organization: From the Atherosclerosis Research Unit (H.N.H., W.J.M., L.D., S.P.A., C.-r.L., C.-h.L., J.H., R.H.S.), the Department of Preventive Medicine (H.N.H., W.J.M., L.D., S.P.A.), the Department of Medicine (H.N.H., C.-r.L., C.-h.L.), and the Department of Radiology (A.G.W.), University of Southern California, Keck School of Medicine, Los Angeles, Calif; the Department of Molecular Pharmacology and Toxicology (H.N.H., J.H.), University of Southern California, School of Pharmacy, Los Angeles, Calif; Kaiser – sequence: 5 givenname: Stanley P. surname: Azen fullname: Azen, Stanley P. organization: From the Atherosclerosis Research Unit (H.N.H., W.J.M., L.D., S.P.A., C.-r.L., C.-h.L., J.H., R.H.S.), the Department of Preventive Medicine (H.N.H., W.J.M., L.D., S.P.A.), the Department of Medicine (H.N.H., C.-r.L., C.-h.L.), and the Department of Radiology (A.G.W.), University of Southern California, Keck School of Medicine, Los Angeles, Calif; the Department of Molecular Pharmacology and Toxicology (H.N.H., J.H.), University of Southern California, School of Pharmacy, Los Angeles, Calif; Kaiser – sequence: 6 givenname: Robert surname: Detrano fullname: Detrano, Robert organization: From the Atherosclerosis Research Unit (H.N.H., W.J.M., L.D., S.P.A., C.-r.L., C.-h.L., J.H., R.H.S.), the Department of Preventive Medicine (H.N.H., W.J.M., L.D., S.P.A.), the Department of Medicine (H.N.H., C.-r.L., C.-h.L.), and the Department of Radiology (A.G.W.), University of Southern California, Keck School of Medicine, Los Angeles, Calif; the Department of Molecular Pharmacology and Toxicology (H.N.H., J.H.), University of Southern California, School of Pharmacy, Los Angeles, Calif; Kaiser – sequence: 7 givenname: Jacob surname: Selhub fullname: Selhub, Jacob organization: From the Atherosclerosis Research Unit (H.N.H., W.J.M., L.D., S.P.A., C.-r.L., C.-h.L., J.H., R.H.S.), the Department of Preventive Medicine (H.N.H., W.J.M., L.D., S.P.A.), the Department of Medicine (H.N.H., C.-r.L., C.-h.L.), and the Department of Radiology (A.G.W.), University of Southern California, Keck School of Medicine, Los Angeles, Calif; the Department of Molecular Pharmacology and Toxicology (H.N.H., J.H.), University of Southern California, School of Pharmacy, Los Angeles, Calif; Kaiser – sequence: 8 givenname: Petar surname: Alaupovic fullname: Alaupovic, Petar organization: From the Atherosclerosis Research Unit (H.N.H., W.J.M., L.D., S.P.A., C.-r.L., C.-h.L., J.H., R.H.S.), the Department of Preventive Medicine (H.N.H., W.J.M., L.D., S.P.A.), the Department of Medicine (H.N.H., C.-r.L., C.-h.L.), and the Department of Radiology (A.G.W.), University of Southern California, Keck School of Medicine, Los Angeles, Calif; the Department of Molecular Pharmacology and Toxicology (H.N.H., J.H.), University of Southern California, School of Pharmacy, Los Angeles, Calif; Kaiser – sequence: 9 givenname: Chao-ran surname: Liu fullname: Liu, Chao-ran organization: From the Atherosclerosis Research Unit (H.N.H., W.J.M., L.D., S.P.A., C.-r.L., C.-h.L., J.H., R.H.S.), the Department of Preventive Medicine (H.N.H., W.J.M., L.D., S.P.A.), the Department of Medicine (H.N.H., C.-r.L., C.-h.L.), and the Department of Radiology (A.G.W.), University of Southern California, Keck School of Medicine, Los Angeles, Calif; the Department of Molecular Pharmacology and Toxicology (H.N.H., J.H.), University of Southern California, School of Pharmacy, Los Angeles, Calif; Kaiser – sequence: 10 givenname: Ci-hua surname: Liu fullname: Liu, Ci-hua organization: From the Atherosclerosis Research Unit (H.N.H., W.J.M., L.D., S.P.A., C.-r.L., C.-h.L., J.H., R.H.S.), the Department of Preventive Medicine (H.N.H., W.J.M., L.D., S.P.A.), the Department of Medicine (H.N.H., C.-r.L., C.-h.L.), and the Department of Radiology (A.G.W.), University of Southern California, Keck School of Medicine, Los Angeles, Calif; the Department of Molecular Pharmacology and Toxicology (H.N.H., J.H.), University of Southern California, School of Pharmacy, Los Angeles, Calif; Kaiser – sequence: 11 givenname: Juliana surname: Hwang fullname: Hwang, Juliana organization: From the Atherosclerosis Research Unit (H.N.H., W.J.M., L.D., S.P.A., C.-r.L., C.-h.L., J.H., R.H.S.), the Department of Preventive Medicine (H.N.H., W.J.M., L.D., S.P.A.), the Department of Medicine (H.N.H., C.-r.L., C.-h.L.), and the Department of Radiology (A.G.W.), University of Southern California, Keck School of Medicine, Los Angeles, Calif; the Department of Molecular Pharmacology and Toxicology (H.N.H., J.H.), University of Southern California, School of Pharmacy, Los Angeles, Calif; Kaiser – sequence: 12 givenname: Alison G. surname: Wilcox fullname: Wilcox, Alison G. organization: From the Atherosclerosis Research Unit (H.N.H., W.J.M., L.D., S.P.A., C.-r.L., C.-h.L., J.H., R.H.S.), the Department of Preventive Medicine (H.N.H., W.J.M., L.D., S.P.A.), the Department of Medicine (H.N.H., C.-r.L., C.-h.L.), and the Department of Radiology (A.G.W.), University of Southern California, Keck School of Medicine, Los Angeles, Calif; the Department of Molecular Pharmacology and Toxicology (H.N.H., J.H.), University of Southern California, School of Pharmacy, Los Angeles, Calif; Kaiser – sequence: 13 givenname: Robert H. surname: Selzer fullname: Selzer, Robert H. organization: From the Atherosclerosis Research Unit (H.N.H., W.J.M., L.D., S.P.A., C.-r.L., C.-h.L., J.H., R.H.S.), the Department of Preventive Medicine (H.N.H., W.J.M., L.D., S.P.A.), the Department of Medicine (H.N.H., C.-r.L., C.-h.L.), and the Department of Radiology (A.G.W.), University of Southern California, Keck School of Medicine, Los Angeles, Calif; the Department of Molecular Pharmacology and Toxicology (H.N.H., J.H.), University of Southern California, School of Pharmacy, Los Angeles, Calif; Kaiser |
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| ContentType | Journal Article |
| Contributor | Alaupovic, Petar Dustin, Laurie Hilton, Joan Spahn, MaryAnn Selzer, Robert H Martinez, George Mahrer, Peter R Hubbard, Molly Sevanian, Alex Gesselman, Christine Proby, Donna Brown, B Greg Dailing, Christopher Trujillo, Christina St John, Jan Stampfer, Meir Badinelli, Joanna Liu, Chao-ran Hodis, Howard N Azen, Stanley P Papa, Agnes Liu, Ci-hua Detrano, Robert Ramirez, Arletta Moya, Charlene Hwang, Juliana Scutella, Phyllis Lee, Zenaida Martizorena, Clifford Moss, Moss Vicario, John Browning, Robert Hutchinson, Michael Morales, Olga Watcher, Frank Pham, Tom Bolusan, Orlando Premen, Andre J Charlson, Martha Engle, Sandra Izumi, Gail Mack, Wendy J Aguirre, Nicole Wilcox, Alison G Selhub, Jacob LaBree, Thelma Zurbrugg, Liny |
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| Keywords | computed tomography homocysteine Thiol Stroke Nervous system diseases intima media thickness vitamin B6 Cardiovascular disease Asymptomatic B-Vitamins randomized controlled trials Folic acid Cyanocobalamin Cerebral disorder Sulfur containing aminoacid Vascular disease folate Homocystein Central nervous system disease Atherosclerosis Computerized axial tomography vitamin B12 High dose Cerebrovascular disease |
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| PublicationTitle | Stroke (1970) |
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| References | e_1_3_2_26_2 e_1_3_2_27_2 e_1_3_2_28_2 (e_1_3_2_18_2) 1994; 2168 e_1_3_2_29_2 (e_1_3_2_19_2) 1995; 9 e_1_3_2_20_2 e_1_3_2_21_2 e_1_3_2_22_2 e_1_3_2_23_2 e_1_3_2_24_2 e_1_3_2_25_2 e_1_3_2_15_2 e_1_3_2_8_2 e_1_3_2_16_2 e_1_3_2_7_2 e_1_3_2_17_2 e_1_3_2_6_2 e_1_3_2_1_2 e_1_3_2_30_2 e_1_3_2_10_2 e_1_3_2_31_2 e_1_3_2_5_2 e_1_3_2_11_2 e_1_3_2_4_2 e_1_3_2_12_2 e_1_3_2_3_2 e_1_3_2_13_2 e_1_3_2_2_2 e_1_3_2_14_2 (e_1_3_2_9_2) 1996; 143 19118238 - Stroke. 2009 Mar;40(3):670-1. doi: 10.1161/STROKEAHA.108.537100. |
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| Snippet | Background and Purpose—
Although plasma total homocysteine (tHcy) levels are associated with cardiovascular disease, it remains unclear whether homocysteine is... Although plasma total homocysteine (tHcy) levels are associated with cardiovascular disease, it remains unclear whether homocysteine is a cause or a marker of... |
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| SubjectTerms | Adult Aged Aged, 80 and over Aorta, Abdominal - diagnostic imaging Atherosclerosis (general aspects, experimental research) Atherosclerosis - diagnostic imaging Atherosclerosis - drug therapy Atherosclerosis - pathology Biological and medical sciences Blood and lymphatic vessels Calcium - metabolism Cardiology. Vascular system Carotid Arteries - diagnostic imaging Coronary Vessels - diagnostic imaging Coronary Vessels - pathology Dietary Supplements Disease Progression Double-Blind Method Echocardiography Female Homocysteine - blood Humans Lipids - blood Male Medical sciences Middle Aged Neurology Patient Compliance Treatment Outcome Vascular diseases and vascular malformations of the nervous system Vitamin B Complex - adverse effects Vitamin B Complex - blood Vitamin B Complex - therapeutic use |
| Subtitle | A Randomized Controlled Trial |
| Title | High-Dose B Vitamin Supplementation and Progression of Subclinical Atherosclerosis |
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