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ISRCTN
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ISRCTN07337345
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ClinicalTrials.gov identifier
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Public title
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Trial of Homocysteine Reduction In the prevention of Vascular Events and Dementia in the elderly
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Scientific title
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Acronym
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THRIVED
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Serial number at source
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112/57
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Study hypothesis
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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?
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Ischaemic vascular disease
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Participants - inclusion criteria
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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)
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/12/2001
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Anticipated end date
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30/11/2003
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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100 elderly patients from Glasgow Royal Infirmary
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Interventions
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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.
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Primary outcome measure(s)
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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)
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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The Health Foundation (UK)
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Trial website
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Publications
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2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16332666
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Contact name
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Dr
David J
Stott
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Address
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Academic Section of Geriatric Medicine
3rd Floor Centre Block
Glasgow Royal Infirmary
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City/town
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Glasgow
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Zip/Postcode
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G4 0SF
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Country
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United Kingdom
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Tel
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+44 (0)141 211 4976
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Fax
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+44-(0)141 211 4944
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Email
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d.j.stott@clinmed.gla.ac.uk
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Sponsor
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The Health Foundation (UK)
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Address
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90 Long Acre
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City/town
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London
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Zip/Postcode
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WC2E 9RA
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Country
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United Kingdom
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Tel
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+44 (0)20 7257 8000
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Fax
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+44 (0)20 7257 8001
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Email
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info@health.org.uk
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Sponsor website:
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http://www.pppfoundation.org.uk/
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Date applied
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12/09/2002
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Last edited
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05/01/2011
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Date ISRCTN assigned
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12/09/2002
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