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NORVIT and WENBIT - Long-term Follow-up

NCT00671346 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 6839

Last updated 2015-11-05

No results posted yet for this study

Summary

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

Conditions

Sponsors & Collaborators

  • University of Tromso

    collaborator OTHER

  • Norwegian Foundation for Health and Rehabilitation

    collaborator OTHER

  • Haukeland University Hospital

    lead OTHER

Principal Investigators

  • Ottar Nygård, MD, PhD · Department of Heart Disease, Haukeland University Hospital

Eligibility

Min Age
27 Years
Max Age
86 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-12-31
Primary Completion
2020-12-31
Completion
2021-01-31

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00671346 on ClinicalTrials.gov