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

ISRCTN ISRCTN07337345
DOI https://doi.org/10.1186/ISRCTN07337345
Secondary identifying numbers 112/57
Submission date
12/09/2002
Registration date
12/09/2002
Last edited
05/01/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymTHRIVED
Study objectives1. 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) studiedIschaemic vascular disease
InterventionPatients 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 typeSupplement
Primary outcome measure1. 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 outcome measuresNot provided at time of registration
Overall study start date01/12/2001
Completion date30/11/2003

Eligibility

Participant type(s)Patient
Age groupSenior
SexNot Specified
Target number of participants100 elderly patients from Glasgow Royal Infirmary
Key inclusion criteria1. 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 criteriaNot provided at time of registration
Date of first enrolment01/12/2001
Date of final enrolment30/11/2003

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

Academic Section of Geriatric Medicine
Glasgow
G4 0SF
United Kingdom

Sponsor information

The Health Foundation (UK)
Charity

90 Long Acre
London
WC2E 9RA
United Kingdom

Phone +44 (0)20 7257 8000
Email info@health.org.uk
Website http://www.pppfoundation.org.uk/
ROR logo "ROR" https://ror.org/02bzj4420

Funders

Funder type

Charity

The Health Foundation (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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