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| [ ...Back to search results ] | [ Print-friendly version ] |
| Older People and Enhanced Neurocognitive function study |
| Source of record | UK Trials |
| ISRCTN | ISRCTN54195799 |
| Date ISRCTN assigned | 04/04/2008 |
| Local reference number(s) | NO5R0009 |
| Public title | Older People and Enhanced Neurocognitive function study |
| Scientific title | |
| Acronym | The OPEN study |
| Disease/condition/study domain | Nerve and cognitive function |
| Study hypothesis | Older people are at increased risk of vitamin B12 deficiency which can lead to severe neurocognitive deficit (e.g. progressive weakness, vision and hearing loss, impairment in communication and co-ordination). The aim of the present study is to assess whether increased dietary intake of crystalline vitamin B12 will improve nerve function and cognitive function in older people with defined low vitamin B12 status. Demonstrating that vitamin B12 dependant nerve and cognitive function impairment is present even in individuals without clinical symptoms will have considerable public health significance. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Application submitted to Cambridgeshire 4 REC, pending as of 03/03/2008. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Healthy volunteers 2. Aged 75 years and over, either sex 3. Defined low B12 status (greater than 107 pmol/l and less than 210 pmol/l) 4. No previous history of diabetes or dementia |
| Participants - exclusion criteria | 1. Pre-existing type I or type II diabetes at baseline 2. Pre-existing dementia at baseline 3. Currently consuming vitamin B12 on a daily basis 4. Mini-Mental State Examination (MMSE) score less than 24 at baseline screen 5. Very low B12 (below 107 pmol/l - Beckman Coulter assay) 6. B12 levels above 210 pmol/l 7. Anaemic 8. History of epilepsy 9. Those with implanted metallic devices such as a pacemaker 10. Alcoholics |
| Patient information material | Patient information on the various different aspects of the study will be available on the website at: http://www.lshtm.ac.uk/nphiru/research/open/ |
| Anticipated start date | 01/07/2008 |
| Anticipated end date | 01/11/2010 |
| Status of trial | Ongoing |
| Target number of participants | 200 |
| Interventions | Daily nutritional supplement of 1 mg vitamin B12 versus placebo. The total duration of treatment is 12 months for both arms. Longer term follow up may be the subject of a separate protocol. |
| Primary outcome measure(s) | Amplitude of tibial motor evoked responses and tibial nerve conduction velocity, measured at 12 months. |
| Secondary outcome measure(s) | 1. Cognitive function: immediate recall, prospective memory, letter search/cancellation, verbal fluency, symbol digit modalities, simple and choice reaction time 2. Timed up and go 3. Psychological health (mood) using the 30-item General Health Questionnaire (GHQ-30) 4. Height and weight 5. History of myocardial infarction (MI) and stroke (reported hospitalisation) All outcomes measured at 12 months. |
| Trial website | http://www.lshtm.ac.uk/nphiru/research/open/ |
| Sources of funding | Food Standards Agency (UK) |
| Sponsor name | London School of Hygiene and Tropical Medicine (LSHTM) (UK) |
| Sponsor details | Keppel Street London United Kingdom WC1E 7HT |
| Sponsor email | penny.ireland@lshtm.ac.uk |
| Sponsor website | http://www.lshtm.ac.uk/ |
| Contact name | Dr Alan Dangour |
| Contact details | London School of Hygiene and Tropical Medicine (LSHTM) Keppel Street London United Kingdom WC1E 7HT |
| Contact telephone | +44 (0)20 7958 8133 |
| Contact fax | +44 (0)20 7958 8111 |
| Contact email | alan.dangour@lshtm.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN54195799 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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