Older People and Enhanced Neurocognitive function study
| ISRCTN | ISRCTN54195799 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54195799 |
| Secondary identifying numbers | NO5R0009 |
- Submission date
- 03/03/2008
- Registration date
- 04/04/2008
- Last edited
- 03/07/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Alan Dangour
Scientific
Scientific
London School of Hygiene and Tropical Medicine (LSHTM)
Keppel Street
London
WC1E 7HT
United Kingdom
| Phone | +44 (0)20 7958 8133 |
|---|---|
| alan.dangour@lshtm.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Patient information can be found at: http://openstudy.lshtm.ac.uk/participant.pdf |
| Scientific title | Older People and Enhanced Neurocognitive function study |
| Study acronym | OPEN |
| Study objectives | 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. |
| Ethics approval(s) | Cambridgeshire 4 REC, 30/04/2008 |
| Health condition(s) or problem(s) studied | Nerve and cognitive function |
| Intervention | 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. |
| Intervention type | Supplement |
| Primary outcome measure | Amplitude of tibial motor evoked responses and tibial nerve conduction velocity, measured at 12 months. |
| Secondary outcome measures | 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. |
| Overall study start date | 01/07/2008 |
| Completion date | 01/11/2010 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Senior |
| Sex | All |
| Target number of participants | 200 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2008 |
| Date of final enrolment | 01/11/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
London School of Hygiene and Tropical Medicine (LSHTM)
London
WC1E 7HT
United Kingdom
WC1E 7HT
United Kingdom
Sponsor information
London School of Hygiene and Tropical Medicine (LSHTM) (UK)
Hospital/treatment centre
Hospital/treatment centre
Keppel Street
London
WC1E 7HT
England
United Kingdom
| penny.ireland@lshtm.ac.uk | |
| Website | http://www.lshtm.ac.uk/ |
"ROR" |
https://ror.org/00a0jsq62 |
Funders
Funder type
Government
Food Standards Agency (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- The Food Standards Agency, FSA
- Location
- United Kingdom
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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 11/03/2011 | Yes | No | |
| Results article | results | 01/09/2015 | Yes | No |
