|
ISRCTN
|
ISRCTN94410159
|
|
DOI
|
10.1186/ISRCTN94410159
|
|
ClinicalTrials.gov identifier
|
|
|
EudraCT number
|
|
|
Public title
|
Homocysteine and B vitamins in cognitive impairment
|
|
Scientific title
|
|
|
Acronym
|
VITACOG
|
|
Serial number at source
|
TP212
|
|
Study hypothesis
|
Lowering plasma total homocysteine by increasing B vitamin supplements will slow the rate of shrinkage of the brain in subjects with mild cognitive impairment and reduce the rate of decline in cognitive test scores
|
|
Lay summary
|
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Cognitive Impairment
|
|
Participants - inclusion criteria
|
Subjects with mild cognitive impairment 70 years and older
|
|
Participants - exclusion criteria
|
1. Dementia
2. Treatment with drugs for dementia
3. Active cancer
4. Vitamin B12 injections
5. Stroke within last three months
6. Inability to undergo Magnetic Resonance Imaging (MRI) scan
|
|
Anticipated start date
|
01/04/2004
|
|
Anticipated end date
|
31/03/2006
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
300
|
|
Interventions
|
Two groups: placebo and treated with folic acid (0.8mg), vitamin B12 (0.5mg) and vitamin B6 (20mg) for two years.
Follow-up: telephone memory test at 30 months after start.
|
|
Primary outcome measure(s)
|
1. Rate of shrinkage of whole brain and or brain regions assessed by volumetric MRI
2. Changes in performance on a variety of cognitive tests
|
|
Secondary outcome measure(s)
|
1. Trial recruitment procedures
2. Conversion to dementia
|
|
Sources of funding
|
1. Medical Research Council (MRC) (UK) (TP212)
2. Charles Wolfson Charitable Trust
|
|
Trial website
|
|
|
Publications
|
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20838622
|
|
Contact name
|
Prof
A. David
Smith
|
|
Address
|
Department of Pharmacology
Mansfield Rd
|
|
City/town
|
Oxford
|
|
Zip/Postcode
|
OX1 3QT
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)1865 271883
|
|
Fax
|
+44 (0)1865 271882
|
|
Email
|
david.smith@pharmacology.ox.ac.uk
|
|
Sponsor
|
University of Oxford (UK)
|
|
Address
|
Medical Sciences Research Services
John Radcliffe Hospital
|
|
City/town
|
Oxford
|
|
Zip/Postcode
|
OX3 9DU
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)1865 222604
|
|
Fax
|
+44 (0)1865 222550
|
|
Email
|
michael.halsey@admin.ox.ac.uk
|
|
Date applied
|
03/05/2005
|
|
Last edited
|
15/09/2010
|
|
Date ISRCTN assigned
|
21/06/2005
|
