Oral vitamin B12 supplementation and cognitive performance in elderly people

ISRCTN	ISRCTN17616323
DOI	https://doi.org/10.1186/ISRCTN17616323
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Simone Eussen
Scientific

Wageningen University
Division of Human Nutrition
P.O. Box 8129
Wageningen
6700 EV
Netherlands

Phone	+31 (0)317 485395
Email	simone.eussen@wur.nl

Study design	Randomised, double blinded, placebo controlled, parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
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	Cognitive performance.
Secondary outcome measures	Blood biochemistry.
Overall study start date	01/05/2003
Completion date	31/10/2004

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	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

Wageningen University,

Wageningen
6700 EV
Netherlands

The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Research organisation

P.O. Box 93245
Den Haag
2509 AE
Netherlands

Charity

Nutricia Research Foundation (The Netherlands)
Private sector organisation / Trusts, charities, foundations (both public and private)

European Union BIOMED (Europe)

No information available

Kelloggs' Benelux (Belgium)

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/08/2006		Yes	No