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
Scientific
Academic Section of Geriatric Medicine
3rd Floor Centre Block
Glasgow Royal Infirmary
Glasgow
G4 0SF
United Kingdom
| Phone | +44 (0)141 211 4976 |
|---|---|
| d.j.stott@clinmed.gla.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 01/12/2001 |
| Completion date | 30/11/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Not Specified |
| Target number of participants | 100 elderly patients from Glasgow Royal Infirmary |
| 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 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Academic Section of Geriatric Medicine
Glasgow
G4 0SF
United Kingdom
G4 0SF
United Kingdom
Sponsor information
The Health Foundation (UK)
Charity
Charity
90 Long Acre
London
WC2E 9RA
United Kingdom
| Phone | +44 (0)20 7257 8000 |
|---|---|
| info@health.org.uk | |
| Website | http://www.pppfoundation.org.uk/ |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
