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Trial of Homocysteine Reduction In the prevention of Vascular Events and Dementia in the elderly

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN07337345
Enrollment
100
Registered
2002-09-12
Start date
2001-12-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischaemic vascular disease Circulatory System Ischaemic vascular disease

Interventions

Patients will receive vitamin folic acid (2 mg) plus vitamin B12 (400 mg) or placebo, vitamin B6 (25 mg) or placebo, and B2 (25 mg), in a factorial 2 by 2 design.

Sponsors

The Health Foundation (UK)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age greater than 65 years 2. Ischaemic vascular disease (at least one of the following: history of angina pectoris, acute myocardial infarction, evidence of major ischaemia or previous infarction on 12-lead electrocardiogram, ischaemic stroke, transient ischaemic attack, intermittent claudication, previous surgery for ischaemic vascular disease)

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

MeasureTime frame
1. Serum HCY, plasma von Willebrand factor, vitamin levels (red cell folate, serum vitamin B12, B2 and B6) 2. Piloting of telephone follow-up of cognition (Telephone Interview for Cognitive Status [TICSm]) and of disability (Barthel Index and short Instrumental Activities for Daily Living [ADL] scale)

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026