Homocysteine and B vitamins in cognitive impairment
| ISRCTN | ISRCTN94410159 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94410159 |
| Protocol serial number | TP212 |
| Sponsor | University of Oxford (UK) |
| Funders | Medical Research Council (MRC) (UK) (TP212), Charles Wolfson Charitable Trust |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Homocysteine and B vitamins in cognitive impairment |
| Study acronym | VITACOG |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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(s) |
1. Rate of shrinkage of whole brain and or brain regions assessed by volumetric MRI |
| Key secondary outcome measure(s) |
1. Trial recruitment procedures |
| Completion date | 31/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 300 |
| Key inclusion criteria | Subjects with mild cognitive impairment 70 years and older |
| Key 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 |
| Date of first enrolment | 01/04/2004 |
| Date of final enrolment | 31/03/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University of Oxford
Oxford
OX1 3QT
United Kingdom
OX1 3QT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
