Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00266487
Status:
COMPLETED
Last Update Posted:
2017-05-08
First Post:
2005-12-15
Brief Title:
The Norwegian Vitamin Trial NORVIT
Sponsor:
University of Tromso
Organization:
University of Tromso
Study Overview
Official Title:
Randomized Trial of Homocysteine-lowering With B Vitamins for Secondary Prevention of Cardiovascular Disease After Acute Myocardial Infarction The Norwegian Vitamin Trial NORVIT
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to examine whether the lowering of blood homocysteine levels by treatment with B vitamins can prevent cardiovascular disease
Detailed Description:
Observational studies have demonstrated that elevated levels of plasma total homocysteine is a risk factor for cardiovascular disease The purpose of this trial is to evaluate the efficacy of homocysteine lowering treatment with B vitamins for secondary prevention in patients who have experienced an acute myocardial infarction
This controlled double-blind multi-centre trial will include 3750 men and women aged 30-85 who have experienced an acute myocardial infarction within 7 days prior to randomization Participants will be randomized in a two-by-two factorial design to receive one of the following four treatments A folic acid 08 mg plus vitamin B12 04 mg and vitamin B6 40 mg per day B folic acid 08 mg plus vitamin B12 04 mg per day C vitamin B6 40 mg per day D placebo
The primary end point during 35 years of follow-up is a composite of recurrent myocardial infarction and stroke and sudden death attributed to coronary artery disease
This controlled double-blind multi-centre trial will include 3750 men and women aged 30-85 who have experienced an acute myocardial infarction within 7 days prior to randomization Participants will be randomized in a two-by-two factorial design to receive one of the following four treatments A folic acid 08 mg plus vitamin B12 04 mg and vitamin B6 40 mg per day B folic acid 08 mg plus vitamin B12 04 mg per day C vitamin B6 40 mg per day D placebo
The primary end point during 35 years of follow-up is a composite of recurrent myocardial infarction and stroke and sudden death attributed to coronary artery disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NRC 138859320 | None | None | None |