Condition category
Circulatory System
Date applied
12/09/2002
Date assigned
12/09/2002
Last edited
05/01/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.pppfoundation.org.uk/

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

  1. 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.

Additional files

Editorial Notes