Contact information
Type
Scientific
Primary contact
Dr David J Stott
ORCID ID
Contact details
Academic Section of Geriatric Medicine
3rd Floor Centre Block
Glasgow Royal Infirmary
Glasgow
G4 0SF
United Kingdom
+44 (0)141 211 4976
d.j.stott@clinmed.gla.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
112/57
Study information
Scientific title
Acronym
THRIVED
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Folic acid, Vitamins B12, B6 and B2
Primary outcome measures
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 outcome measures
Not provided at time of registration
Overall trial start date
01/12/2001
Overall trial end date
30/11/2003
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Senior
Gender
Not Specified
Target number of participants
100 elderly patients from Glasgow Royal Infirmary
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/12/2001
Recruitment end date
30/11/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Academic Section of Geriatric Medicine
Glasgow
G4 0SF
United Kingdom
Sponsor information
Organisation
The Health Foundation (UK)
Sponsor details
90 Long Acre
London
WC2E 9RA
United Kingdom
+44 (0)20 7257 8000
info@health.org.uk
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
The Health Foundation (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16332666
Publication citations
-
Results
Stott DJ, MacIntosh G, Lowe GD, Rumley A, McMahon AD, Langhorne P, Tait RC, O'Reilly DS, Spilg EG, MacDonald JB, MacFarlane PW, Westendorp RG, Randomized controlled trial of homocysteine-lowering vitamin treatment in elderly patients with vascular disease., Am. J. Clin. Nutr., 2005, 82, 6, 1320-1326.