Nerve and cognitive function Nervous System Diseases Cognitive function
Conditions
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.
Sponsors
London School of Hygiene and Tropical Medicine (LSHTM) (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amplitude of tibial motor evoked responses and tibial nerve conduction velocity, measured at 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Outcome results
None listed