NCT00217178

Brief Summary

Study Objective: 1\. To evaluate whether combined therapy with folic acid 2.5 mg/day, vitamin B6 50 mg/day and vitamin B12 1000 micrograms/day vs placebo reduces the rate of atherosclerosis progression, as evaluated by quantitative B-mode carotid ultrasound (US).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
900

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2000

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

September 22, 2005

Status Verified

October 1, 2004

First QC Date

September 16, 2005

Last Update Submit

September 16, 2005

Conditions

AtherosclerosisCardiovascular Disease

Keywords

AtherosclerosisCV Risk FactorsHomocysteineCV diseaseCardiovascular disease

Outcome Measures

Primary Outcomes (1)

  • The change over time (annualized progression slope) in the mean maximum IMT (the mean maximum IMT slope) defined as the average of the maximum IMT across the 12 preselected carotid arterial segments.

Secondary Outcomes (1)

  • The change over time (annualized progression slope) in the single maximum IMT amongst any of the same preselected carotid artery segments, i.e. the hemodynamically most important lesson.

Interventions

Vitamins: Folic acid, B6, B12DRUG

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamilton Health Sciences Corp.

Hamilton, Ontario, L8L 2X2, Canada

Location

Related Publications (1)

  • Held C, Sumner G, Sheridan P, McQueen M, Smith S, Dagenais G, Yusuf S, Lonn E. Correlations between plasma homocysteine and folate concentrations and carotid atherosclerosis in high-risk individuals: baseline data from the Homocysteine and Atherosclerosis Reduction Trial (HART). Vasc Med. 2008 Nov;13(4):245-53. doi: 10.1177/1358863X08092102.

    PMID: 18940900DERIVED

MeSH Terms

Conditions

AtherosclerosisCardiovascular Diseases

Interventions

Vitamin B 12

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

CorrinoidsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Eva M Lonn, MD MSc FRCPC FACC

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 22, 2005

Study Start

January 1, 2000

Study Completion

October 1, 2005

Last Updated

September 22, 2005

Record last verified: 2004-10

Locations

CA(1)