← Human Trials & Peer-Reviewed Studies
The Norwegian Vitamin Trial (NORVIT)
Plain-language guide to NCT00266487: not phased randomized trial of Cyanocobalamin (Vitamin B12), 3750 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00266487
- Phase
- not phased
- Status
- completed
- Start
- 1998-12
- Completion (planned or actual)
- 2004-03
- Participants
- 3750
- Design
- randomized, double-blind, treatment
- Conditions studied
- Acute Myocardial Infarction
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this not phased trial, researchers set out to test Cyanocobalamin (Vitamin B12).
The registry classes the interventions as drug.
More on the Plan
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.
Who Took Part
Enrollment: 3750 planned participants were the target.
It was open to people of any sex aged from 30 years up to 85 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Acute myocardial infarction within 7 days prior to randomization. Men and women aged 30-85 years. Written informed consent.
The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: expected poor compliance.
How the Study Was Run
It was run as a randomized, factorial and double-blind study.
The participants were allocated by chance, so the Cyanocobalamin (Vitamin B12) group and the comparison group should start out alike.
As a double-blind Cyanocobalamin (Vitamin B12) study, the assignments were hidden from both participants and investigators until the end.
It started in 1998-12 with completion listed for 2004-03.
It ran at 1 site in Norway.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): The primary end point was a composite of. nonfatal myocardial infarction,. fatal myocardial infarction,.
It also tracked 16 secondary outcomes, for example Individual components of the primary end point, i.e, Nonfatal myocardial infarction, Fatal myocardial infarction, Nonfatal stroke, Fatal stroke and In addition the following secondary outcomes:.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 3750 people.
With 3750 participants it is a large trial for this field.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.
Our Notes on the Compound
Cyanocobalamin (Vitamin B12): A synthetic form of vitamin B12 (cobalamin), an essential nutrient for DNA synthesis, red blood cell formation and neurological function.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.