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WENBIT - Western Norway B Vitamin Intervention Trial (WENBIT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00354081
First Posted: July 20, 2006
Last Update Posted: July 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
The Research Council of Norway
Norwegian Foundation for Health and Rehabilitation
Norwegian Heart and Lung Patient Organisation
The Royal Norwegian Ministry of Health
Locus for Homocysteine and Related Vitamins, University of Bergen, Norway
Locus for Cardiac Research, University of Bergen, Norway
Foundation to Promote Research into Functional Vitamin B12 Deficiency, Bergen, Norway
Alpharma Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Information provided by (Responsible Party):
Haukeland University Hospital
No Study Results Posted on ClinicalTrials.gov for this Study
  Study Status: This study has been completed.
  Study Completion Date: February 2008
  Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Publications:
Nexo E, Hvas AM, Bleie Ø, Refsum H, Fedosov SN, Vollset SE, Schneede J, Nordrehaug JE, Ueland PM, Nygard OK. Holo-transcobalamin is an early marker of changes in cobalamin homeostasis. A randomized placebo-controlled study. Clin Chem. 2002 Oct;48(10):1768-71.
Bor MV, Refsum H, Bisp MR, Bleie Ø, Schneede J, Nordrehaug JE, Ueland PM, Nygard OK, Nexø E. Plasma vitamin B6 vitamers before and after oral vitamin B6 treatment: a randomized placebo-controlled study. Clin Chem. 2003 Jan;49(1):155-61.
Holm PI, Bleie Ø, Ueland PM, Lien EA, Refsum H, Nordrehaug JE, Nygård O. Betaine as a determinant of postmethionine load total plasma homocysteine before and after B-vitamin supplementation. Arterioscler Thromb Vasc Biol. 2004 Feb;24(2):301-7. Epub 2003 Dec 29.
Bleie Ø, Refsum H, Ueland PM, Vollset SE, Guttormsen AB, Nexo E, Schneede J, Nordrehaug JE, Nygård O. Changes in basal and postmethionine load concentrations of total homocysteine and cystathionine after B vitamin intervention. Am J Clin Nutr. 2004 Sep;80(3):641-8.
Gavasso S, Nygård O, Pedersen ER, Aarseth JH, Bleie O, Myhr KM, Vedeler CA. Fcgamma receptor IIIA polymorphism as a risk-factor for coronary artery disease. Atherosclerosis. 2005 Jun;180(2):277-82. Epub 2005 Jan 25.
Mørkbak AL, Hvas AM, Lloyd-Wright Z, Sanders TA, Bleie O, Refsum H, Nygaard OK, Nexø E. Effect of vitamin B12 treatment on haptocorrin. Clin Chem. 2006 Jun;52(6):1104-11. Epub 2006 Apr 13.
Ulvik B, Wentzel-Larsen T, Hanestad BR, Omenaas E, Nygård OK. Relationship between provider-based measures of physical function and self-reported health-related quality of life in patients admitted for elective coronary angiography. Heart Lung. 2006 Mar-Apr;35(2):90-100.
Bleie Ø, Semb AG, Grundt H, Nordrehaug JE, Vollset SE, Ueland PM, Nilsen DW, Bakken AM, Refsum H, Nygård OK. Homocysteine-lowering therapy does not affect inflammatory markers of atherosclerosis in patients with stable coronary artery disease. J Intern Med. 2007 Aug;262(2):244-53.
Ulvik B, Nygård O, Hanestad BR, Wentzel-Larsen T, Wahl AK. Associations between disease severity, coping and dimensions of health-related quality of life in patients admitted for elective coronary angiography - a cross sectional study. Health Qual Life Outcomes. 2008 May 29;6:38. doi: 10.1186/1477-7525-6-38.
Ulvik B, Bjelland I, Hanestad BR, Omenaas E, Wentzel-Larsen T, Nygård O. Comparison of the Short Form 36 and the Hospital Anxiety and Depression Scale measuring emotional distress in patients admitted for elective coronary angiography. Heart Lung. 2008 Jul-Aug;37(4):286-95. doi: 10.1016/j.hrtlng.2007.08.001.
Ebbing M, Bleie Ø, Ueland PM, Nordrehaug JE, Nilsen DW, Vollset SE, Refsum H, Pedersen EK, Nygård O. Mortality and cardiovascular events in patients treated with homocysteine-lowering B vitamins after coronary angiography: a randomized controlled trial. JAMA. 2008 Aug 20;300(7):795-804. doi: 10.1001/jama.300.7.795.
Lønnebakken MT, Bleie O, Strand E, Staal EM, Nygård OK, Gerdts E. Myocardial contrast echocardiography in assessment of stable coronary artery disease at intermediate dobutamine-induced stress level. Echocardiography. 2009 Jan;26(1):52-60. doi: 10.1111/j.1540-8175.2008.00738.x.
Lønnebakken MT, Staal EM, Bleie Ø, Strand E, Nygård OK, Gerdts E. Quantitative contrast stress echocardiography in assessment of restenosis after percutaneous coronary intervention in stable coronary artery disease. Eur J Echocardiogr. 2009 Oct;10(7):858-64. doi: 10.1093/ejechocard/jep090. Epub 2009 Jun 23.
Manger MS, Strand E, Ebbing M, Seifert R, Refsum H, Nordrehaug JE, Nilsen DW, Drevon CA, Tell GS, Bleie O, Vollset SE, Pedersen ER, Nygård O. Dietary intake of n-3 long-chain polyunsaturated fatty acids and coronary events in Norwegian patients with coronary artery disease. Am J Clin Nutr. 2010 Jul;92(1):244-51. doi: 10.3945/ajcn.2010.29175. Epub 2010 May 19.
Løland KH, Bleie O, Blix AJ, Strand E, Ueland PM, Refsum H, Ebbing M, Nordrehaug JE, Nygård O. Effect of homocysteine-lowering B vitamin treatment on angiographic progression of coronary artery disease: a Western Norway B Vitamin Intervention Trial (WENBIT) substudy. Am J Cardiol. 2010 Jun 1;105(11):1577-84. doi: 10.1016/j.amjcard.2010.01.019. Epub 2010 Apr 10.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Strand E, Pedersen ER, Svingen GF, Olsen T, Bjørndal B, Karlsson T, Dierkes J, Njølstad PR, Mellgren G, Tell GS, Berge RK, Svardal A, Nygård O. Serum Acylcarnitines and Risk of Cardiovascular Death and Acute Myocardial Infarction in Patients With Stable Angina Pectoris. J Am Heart Assoc. 2017 Feb 3;6(2). pii: e003620. doi: 10.1161/JAHA.116.003620.
Ding Y, Pedersen ER, Svingen GF, Helgeland Ø, Gregory JF, Løland KH, Meyer K, Tell GS, Ueland PM, Nygård OK. Methylenetetrahydrofolate Dehydrogenase 1 Polymorphisms Modify the Associations of Plasma Glycine and Serine With Risk of Acute Myocardial Infarction in Patients With Stable Angina Pectoris in WENBIT (Western Norway B Vitamin Intervention Trial). Circ Cardiovasc Genet. 2016 Dec;9(6):541-547. doi: 10.1161/CIRCGENETICS.116.001483. Epub 2016 Nov 21.
Borgeraas H, Hertel JK, Seifert R, Berge RK, Bohov P, Ueland PM, Nygård O, Hjelmesæth J. Serum trans fatty acids, asymmetric dimethylarginine and risk of acute myocardial infarction and mortality in patients with suspected coronary heart disease: a prospective cohort study. Lipids Health Dis. 2016 Feb 27;15:38. doi: 10.1186/s12944-016-0204-9.
Ding Y, Svingen GF, Pedersen ER, Gregory JF, Ueland PM, Tell GS, Nygård OK. Plasma Glycine and Risk of Acute Myocardial Infarction in Patients With Suspected Stable Angina Pectoris. J Am Heart Assoc. 2015 Dec 31;5(1). pii: e002621. doi: 10.1161/JAHA.115.002621.
Rebnord EW, Pedersen ER, Strand E, Svingen GF, Meyer K, Schartum-Hansen H, Løland KH, Seifert R, Ueland PM, Nilsen DW, Nordrehaug JE, Nygård O. Glycated hemoglobin and long-term prognosis in patients with suspected stable angina pectoris without diabetes mellitus: a prospective cohort study. Atherosclerosis. 2015 May;240(1):115-20. doi: 10.1016/j.atherosclerosis.2015.02.053. Epub 2015 Feb 28.
Borgeraas H, Hertel JK, Svingen GF, Seifert R, Pedersen EK, Schartum-Hansen H, Hjelmesæth J, Nygård O. Association of body mass index with risk of acute myocardial infarction and mortality in Norwegian male and female patients with suspected stable angina pectoris: a prospective cohort study. BMC Cardiovasc Disord. 2014 May 21;14:68. doi: 10.1186/1471-2261-14-68.
Midttun O, Townsend MK, Nygård O, Tworoger SS, Brennan P, Johansson M, Ueland PM. Most blood biomarkers related to vitamin status, one-carbon metabolism, and the kynurenine pathway show adequate preanalytical stability and within-person reproducibility to allow assessment of exposure or nutritional status in healthy women and cardiovascular patients. J Nutr. 2014 May;144(5):784-90. doi: 10.3945/jn.113.189738. Epub 2014 Mar 19.
Strand E, Pedersen ER, Svingen GF, Schartum-Hansen H, Rebnord EW, Bjørndal B, Seifert R, Bohov P, Meyer K, Hiltunen JK, Nordrehaug JE, Nilsen DW, Berge RK, Nygård O. Dietary intake of n-3 long-chain polyunsaturated fatty acids and risk of myocardial infarction in coronary artery disease patients with or without diabetes mellitus: a prospective cohort study. BMC Med. 2013 Oct 8;11:216. doi: 10.1186/1741-7015-11-216.
Løland KH, Bleie Ø, Strand E, Ueland PM, Nordrehaug JE, Garcia-Garcia HM, Serruys PW, Nygård O. Effect of folic acid supplementation on levels of circulating Monocyte Chemoattractant Protein-1 and the presence of intravascular ultrasound derived virtual histology thin-cap fibroatheromas in patients with stable angina pectoris. PLoS One. 2013 Jul 25;8(7):e70101. doi: 10.1371/journal.pone.0070101. Print 2013.
Løland KH, Bleie O, Borgeraas H, Strand E, Ueland PM, Svardal A, Nordrehaug JE, Nygård O. The association between progression of atherosclerosis and the methylated amino acids asymmetric dimethylarginine and trimethyllysine. PLoS One. 2013 May 29;8(5):e64774. doi: 10.1371/journal.pone.0064774. Print 2013.
Midttun O, Ulvik A, Ringdal Pedersen E, Ebbing M, Bleie O, Schartum-Hansen H, Nilsen RM, Nygård O, Ueland PM. Low plasma vitamin B-6 status affects metabolism through the kynurenine pathway in cardiovascular patients with systemic inflammation. J Nutr. 2011 Apr 1;141(4):611-7. doi: 10.3945/jn.110.133082. Epub 2011 Feb 10.


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