Oral vitamin B12 supplementation and cognitive performance in elderly people
| ISRCTN | ISRCTN17616323 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17616323 |
| Protocol serial number | N/A |
| Sponsor | The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) |
| Funders | Nutricia Research Foundation (The Netherlands), European Union BIOMED (Europe), Kelloggs' Benelux (Belgium) |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 09/11/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Simone Eussen
Scientific
Scientific
Wageningen University
Division of Human Nutrition
P.O. Box 8129
Wageningen
6700 EV
Netherlands
| Phone | +31 (0)317 485395 |
|---|---|
| simone.eussen@wur.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, double blinded, placebo controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | Brain12 study |
| Study objectives | Counteract the process of cognitive impairment in elderly people with mild vitamin B12 deficiency through oral supplementation with vitamin B12 or a combination of vitamin B12 with folic acid |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Vitamin B12 deficiency |
| Intervention | 1. 1,000 microgram vitamin B12/day 2. 1,000 microgram vitamin B12 and 400 microgram folic acid/day 3. Placebo |
| Intervention type | Supplement |
| Primary outcome measure(s) |
Cognitive performance. |
| Key secondary outcome measure(s) |
Blood biochemistry. |
| Completion date | 31/10/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 195 |
| Key inclusion criteria | 1. Men and women aged 70 years or older 2. Mild vitamin B12 deficiency defined as vitamin B12 concentration between 100 and 300 picomol/L and MMA concentration greater than 0.32 micromol/L and creatinine concentration less than 120 micromol/L |
| Key exclusion criteria | 1. Severe cognitive impairment 2. Anemia 3. Gastrointestinal surgery 4. Use of vitamin B12 injections or supplements containing > 50 micrograms vitamin B12 and/or 25 micrograms folic acid 5. Less than 90% compliance during a 2 week placebo run in period 6. No written informed consent 7. Participation in other studies |
| Date of first enrolment | 01/05/2003 |
| Date of final enrolment | 31/10/2004 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Wageningen University,
Wageningen
6700 EV
Netherlands
6700 EV
Netherlands
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 | 01/08/2006 | Yes | No |
