NORVIT and WENBIT - Long-term Follow-up (NORVITWENBIT)
Two large homocysteine-lowering B-vitamin intervention trials have been performed in Norway during the period 1998 to 2005, NORVIT and WENBIT. The main objective in these trials was to study the clinical effects of homocysteine-lowering therapy with folic acid and vitamin B12 in patients with established coronary artery disease. Follow-up was terminated for NORVIT on Marc 31st 2004 and for WENBIT October 5th 2005, and none of the two trials proved any protective effect of the B-vitamin intervention on cardiovascular outcomes.
There is so far no data on possible long-term effects following years of such B-vitamin treatment.
Thus, the main objective of the combinded NORVIT-WENBIT study will will be to evaluate the long-term effect of the B-vitamin intervention on incident life-style diseases including cardiovascular disease, diabetes, osteoporotic fractures and cancer.
A secondary object will be the identification of risk phenotypes or genotypes, and if such risk associations are midified by the B-vitamin intervention
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Combined Analyses and Long-term Follow-up in the Two Norwegian Homocysteine-Lowering B-Vitamin Trials NORVIT and WENBIT|
- Possible effects of B-vitamin treatment on risk of developing cancer during the trial periods (completed by 2004 and 2005) and during post-trial follow-up. [ Time Frame: 1998-2014 ] [ Designated as safety issue: Yes ]
- The possible effects of B-vitamin treatment on major cardiovascular events, all cause mortality and cause specific death during the trial periods (completed by 2004 and 2005) and during post-trial follow-up. [ Time Frame: 1998-2014 ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 1998|
|Estimated Study Completion Date:||January 2021|
|Estimated Primary Completion Date:||December 2020 (Final data collection date for primary outcome measure)|
Participants in NORVIT and WENBIT allocated to daily oral treatment with folic acid 0.8 mg and vitamin B12 0.4 mg
Participants in NORVIT and WENBIT allocated to daily oral treatment with folic acid 0.8 mg, vitamin B12 0.4 mg and B6 40 mg.
Participants in NORVIT and WENBIT allocated to daily oral treatment with vitamin B6 40 mg.
Participants in NORVIT and WENBIT allocated to daily oral treatment with placebo
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00671346
|Department of Heart Disease, Haukeland University Hospital|
|Bergen, Norway, 5021|
|University of Tromsø|
|Tromsø, Norway, 9037|
|Study Chair:||Ottar Nygård, MD, PhD||Department of Heart Disease, Haukeland University Hospital|