Homocysteine and B vitamins in cognitive impairment
| ISRCTN | ISRCTN94410159 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94410159 |
| Secondary identifying numbers | TP212 |
- Submission date
- 03/05/2005
- Registration date
- 21/06/2005
- Last edited
- 14/09/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof A. David Smith
Scientific
Scientific
Department of Pharmacology
Mansfield Rd
Oxford
OX1 3QT
United Kingdom
| Phone | +44 (0)1865 271883 |
|---|---|
| david.smith@pharmacology.ox.ac.uk |
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 | Homocysteine and B vitamins in cognitive impairment |
| Study acronym | VITACOG |
| 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 |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Cognitive Impairment |
| Intervention | 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. |
| Intervention type | Supplement |
| Primary outcome measure | 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 measures | 1. Trial recruitment procedures 2. Conversion to dementia |
| Overall study start date | 01/04/2004 |
| Overall study end date | 31/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 300 |
| Participant inclusion criteria | Subjects with mild cognitive impairment 70 years and older |
| Participant 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 |
| Recruitment start date | 01/04/2004 |
| Recruitment end date | 31/03/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Oxford
Oxford
OX1 3QT
United Kingdom
OX1 3QT
United Kingdom
Sponsor information
University of Oxford (UK)
University/education
University/education
Medical Sciences Research Services
John Radcliffe Hospital
Oxford
OX3 9DU
England
United Kingdom
| Phone | +44 (0)1865 222604 |
|---|---|
| michael.halsey@admin.ox.ac.uk | |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK) (TP212)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Charles Wolfson Charitable Trust
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 | 08/09/2010 | Yes | No | |
| Results article | results | 01/07/2015 | Yes | No |
