A pilot study for the VITAL trial (Vitamins and Aspirin for the Treatment of Dementia)

ISRCTN	ISRCTN30537186
DOI	https://doi.org/10.1186/ISRCTN30537186
Secondary identifying numbers	SPGS773

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 31/08/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Marc Budge
Scientific

Department of Pharmacology
Radcliffe Infirmary NHS Trust
Woodstock Road
Oxford
OX2 6HE
United Kingdom

Phone	+44 (0)1865 224356

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study 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(s)	Not provided at time of registration
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
Primary outcome measure	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 study start date	01/06/1999
Overall study end date	31/05/2000

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Not provided at time of registration
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 exclusion criteria	Not provided at time of registration
Recruitment start date	01/06/1999
Recruitment end date	31/05/2000

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Pharmacology

Oxford
OX2 6HE
United Kingdom

Sponsor information

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

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive South East (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	01/07/2003		Yes	No