Condition category
Nervous System Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
31/08/2012
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 Marc Budge

ORCID ID

Contact details

Department of Pharmacology
Radcliffe Infirmary NHS Trust
Woodstock Road
Oxford
OX2 6HE
United Kingdom
+44 (0)1865 224356

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SPGS773

Study information

Scientific title

Acronym

VITAL

Study hypothesis

The trial will address the following research objectives:
1. Feasibility and practicability of identifying dementia patients from hospital registers and general practice and the validity and acceptability of asking the doctor in charge of such patients to provide diagnostic data using a one page Medical Referral form before the patient attends the study clinic run by specialist nurses.
2. Efficacy and acceptability of the 2 methods of assessment of cognitive function, Activities of Daily Living Assessment and evaluation of the response rate to an invitation to attend a screening visit, enter run-in, agree to be randomised and attend a follow-up visit and comply with instructions to take the study treatments.
3. Evaluation of the absorption and biochemical effects of aspirin, vitamins E and C, and folic acid and vitamin B12 on markers of platelet function and oxidative damage and on blood vitamin and homocysteine levels when administered alone or in combination in patients with dementia.

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

Not specified

Trial type

Treatment

Patient information sheet

Condition

Nervous system diseases: Dementia

Intervention

1. Aspirin 75 mg or placebo
2. Vitamin E (600 mg) and Vitamin C (250 mg) or placebo
3. Folic acid (2 mg) and Vitamin B-12 (1 mg) or placebo

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The pilot study will determine the feasibility and practicability of the procedures required for recruitment and monitoring of the effects of aspirin and vitamin supplements in a clinical trial in patients with dementia. It will determine the response rates to a request to attend screening, randomisation and follow up visits and compliance with instructions to take study medication. The study will evaluate two alternative methods of assessing cognitive function and evaluate the validity of obtaining medical information on prior vascular disease and current medication about patient from carers. Information gained will guide the choice of treatment to be adopted in a large trial to assess whether such treatments may delay the requirement for institutionalisation in this population.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/1999

Overall trial end date

31/05/2000

Reason abandoned

Eligibility

Participant inclusion criteria

Male and female patients of all ages with a clinical diagnosis of dementia (according to Diagnostic and Statistical Manual of Mental Disorders, Fourth edition [DSM IV] criteria) of mild to moderate severity will be eligible to participate.
Concomitant therapy prescribed to affect cognitive function (e.g. Donepezil etc.) will be permitted provided the participant has been taking it for at least 3 months before the screening visit and intends to continue taking it for the duration of the VITAL treatment period.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/06/1999

Recruitment end date

31/05/2000

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Pharmacology
Oxford
OX2 6HE
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive South East (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

1. 2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12823643

Publication citations

  1. Results

    Clarke R, Harrison G, Richards S, , Effect of vitamins and aspirin on markers of platelet activation, oxidative stress and homocysteine in people at high risk of dementia., J. Intern. Med., 2003, 254, 1, 67-75.

Additional files

Editorial Notes