| Source of record | UK Trials |
| ISRCTN | ISRCTN07337345 |
| Date ISRCTN assigned | 12/09/2002 |
| Local reference number(s) | 112/57 |
| Public title | Trial of Homocysteine Reduction In the prevention of Vascular Events and Dementia in the elderly |
| Scientific title |
|
| Acronym | THRIVED |
| Disease/condition/study domain | Ischaemic vascular disease |
| 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? |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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) |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/12/2001 |
| Anticipated end date | 30/11/2003 |
| Status of trial | Completed |
| Target number of participants | 100 elderly patients from Glasgow Royal Infirmary |
| Interventions | 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. |
| 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) |
| Secondary outcome measure(s) | Not provided at time of registration |
| Publications | Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=Retrieve&db=PubMed&list_uids=16332666 |
| Sources of funding | The Health Foundation (UK) |
| Sponsor name | The Health Foundation (UK) |
| Sponsor details | 90 Long Acre
London
United Kingdom
WC2E 9RA |
| Sponsor telephone | +44 (0)20 7257 8000 |
| Sponsor fax | +44 (0)20 7257 8001 |
| Sponsor email | info@health.org.uk |
| Sponsor website | http://www.pppfoundation.org.uk/ |
| Contact name | Professor David J Stott |
| Contact details | Academic Section of Geriatric Medicine
3rd Floor Centre Block
Glasgow Royal Infirmary
Glasgow
United Kingdom
G4 0SF |
| Contact telephone | +44 (0)141 211 4976 |
| Contact fax | +44-(0)141-211-4944 |
| Contact email | d.j.stott@clinmed.gla.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN07337345 |
| Date last extracted from ISRCTN register | 17/04/2008 |
