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ISRCTN
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ISRCTN54195799
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ClinicalTrials.gov identifier
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Public title
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Older People and Enhanced Neurocognitive function study
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Scientific title
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Acronym
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The OPEN study
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Serial number at source
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NO5R0009
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Study hypothesis
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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.
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Ethics approval
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Application submitted to Cambridgeshire 4 REC, pending as of 03/03/2008.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Nerve and cognitive function
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/07/2008
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Anticipated end date
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01/11/2010
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Status of trial
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Ongoing
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Patient information material
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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/
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Target number of participants
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200
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Interventions
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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.
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Primary outcome measure(s)
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Amplitude of tibial motor evoked responses and tibial nerve conduction velocity, measured at 12 months.
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Secondary outcome measure(s)
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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.
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Sources of funding
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Food Standards Agency (UK)
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Trial website
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http://www.lshtm.ac.uk/nphiru/research/open/
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Publications
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Contact name
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Dr
Alan
Dangour
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Address
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London School of Hygiene and Tropical Medicine (LSHTM)
Keppel Street
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City/town
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London
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Zip/Postcode
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WC1E 7HT
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Country
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United Kingdom
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Tel
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+44 (0)20 7958 8133
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Fax
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+44 (0)20 7958 8111
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Email
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alan.dangour@lshtm.ac.uk
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Sponsor
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London School of Hygiene and Tropical Medicine (LSHTM) (UK)
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Address
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Keppel Street
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City/town
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London
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Zip/Postcode
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WC1E 7HT
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Country
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United Kingdom
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Email
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penny.ireland@lshtm.ac.uk
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Sponsor website:
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http://www.lshtm.ac.uk/
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Date applied
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03/03/2008
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Last edited
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04/04/2008
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Date ISRCTN assigned
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04/04/2008
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