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NORVIT and WENBIT - Long-term Follow-up (NORVITWENBIT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Tromso
Norwegian Foundation for Health and Rehabilitation
Information provided by (Responsible Party):
Ottar Kjell Nygård, Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT00671346
First received: April 29, 2008
Last updated: November 4, 2015
Last verified: November 2015
  Purpose

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


Condition
Cancer
Myocardial Infarction
Cerebrovascular Stroke

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 6839
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)
Groups/Cohorts
1
Participants in NORVIT and WENBIT allocated to daily oral treatment with folic acid 0.8 mg and vitamin B12 0.4 mg
2
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.
3
Participants in NORVIT and WENBIT allocated to daily oral treatment with vitamin B6 40 mg.
4
Participants in NORVIT and WENBIT allocated to daily oral treatment with placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   27 Years to 86 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population for combined analyses consists of the of 3 749 + 3 090 = 6 839 men and women aged 27 - 86 years when randomised in the NORVIT and WENBIT trials between December 1998 and April 2004. All patients in NORVIT were randomised following an acute myocardial infarction, whereas patients in WENBIT were randomised following coronary angiography, of which 85% had stable angina pectoris, 10% had acute myocardial infarction and 5% had unstable angina pectoris at baseline.
Criteria

Inclusion Criteria:

  • Randomised in the Norwegian Vitamin Trial (NORVIT) or in the Western Norway B-Vitamin Intervention Trial (WENBIT)

Exclusion Criteria:

  • Withdrawn consent to participate in study cohort for post-trial observational follow-up
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671346

Locations
Norway
Department of Heart Disease, Haukeland University Hospital
Bergen, Norway, 5021
University of Tromsø
Tromsø, Norway, 9037
Sponsors and Collaborators
Haukeland University Hospital
University of Tromso
Norwegian Foundation for Health and Rehabilitation
Investigators
Study Chair: Ottar Nygård, MD, PhD Department of Heart Disease, Haukeland University Hospital
  More Information

Additional Information:
Publications:

Responsible Party: Ottar Kjell Nygård, MD, PhD, Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT00671346     History of Changes
Other Study ID Numbers: NSD-17895  REK-267.07  DT-08/00230-2/RVB  Hdir-08/623- 
Study First Received: April 29, 2008
Last Updated: November 4, 2015
Health Authority: Norway: Norwegian Social Science Data Services
Norway: Data Protection Authority

Keywords provided by Haukeland University Hospital:
Cancer
Coronary artery disease
Myocardial infarction
Cerebrovascular stroke
Homocysteine
Vitamin B Complex
Folic acid
Vitamin B12
Vitamin B6
Pyridoxal phosphate
Osteoporotic fractures
Diabetes

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Stroke
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vitamins
Vitamin B 12
Hydroxocobalamin
Vitamin B 6
Folic Acid
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics

ClinicalTrials.gov processed this record on December 07, 2016