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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr David J Stott
Scientific

Academic Section of Geriatric Medicine
3rd Floor Centre Block
Glasgow Royal Infirmary
Glasgow
G4 0SF
United Kingdom

Phone	+44 (0)141 211 4976
Email	d.j.stott@clinmed.gla.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	THRIVED
Study objectives	1. What are the effects of vitamin combinations (comprising of folic acid plus B12, B6 and B2, each alone and in combination) on serum homocysteine (HCY) in elderly patients with vascular disease? 2. Is telephone follow-up of cognitive function and of disability practicable in this cohort of patients?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Ischaemic vascular disease
Intervention	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.
Intervention type	Supplement
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/11/2003

Participant type(s)	Patient
Age group	Senior
Sex	Not Specified
Target sample size at registration	100
Key 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)
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/12/2001
Date of final enrolment	30/11/2003

Academic Section of Geriatric Medicine

Glasgow
G4 0SF
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2005		Yes	No