Older People and Enhanced Neurocognitive function study

ISRCTN	ISRCTN54195799
DOI	https://doi.org/10.1186/ISRCTN54195799
Protocol serial number	NO5R0009
Sponsor	London School of Hygiene and Tropical Medicine (LSHTM) (UK)
Funder	Food Standards Agency (UK)

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

London School of Hygiene and Tropical Medicine (LSHTM)
Keppel Street
London
WC1E 7HT
United Kingdom

Phone	+44 (0)20 7958 8133
Email	alan.dangour@lshtm.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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(s)	Amplitude of tibial motor evoked responses and tibial nerve conduction velocity, measured at 12 months.
Key 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.
Completion date	01/11/2010

Eligibility

Participant type(s)	Healthy volunteer
Age group	Senior
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

London School of Hygiene and Tropical Medicine (LSHTM)

London
WC1E 7HT
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	01/09/2015		Yes	No
Protocol article	protocol	11/03/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes