Contact information
Type
Scientific
Primary contact
Dr Simone Eussen
ORCID ID
Contact details
Wageningen University
Division of Human Nutrition
P.O. Box 8129
Wageningen
6700 EV
Netherlands
+31 (0)317 485395
simone.eussen@wur.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Brain12 study
Study hypothesis
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
Ethics approval received from the local medical ethics committee
Study design
Randomised, double blinded, placebo controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Vitamin B12, folic acid
Primary outcome measure
Cognitive performance.
Secondary outcome measures
Blood biochemistry.
Overall trial start date
01/05/2003
Overall trial end date
31/10/2004
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
195
Participant 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
Recruitment start date
01/05/2003
Recruitment end date
31/10/2004
Locations
Countries of recruitment
Netherlands
Trial participating centre
Wageningen University,
Wageningen
6700 EV
Netherlands
Sponsor information
Organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Sponsor details
P.O. Box 93245
Den Haag
2509 AE
Netherlands
+31 (0)70 349 5111
info@zonmw.nl
Sponsor type
Research organisation
Website
Funders
Funder type
Charity
Funder name
Nutricia Research Foundation (The Netherlands)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Netherlands
Funder name
European Union BIOMED (Europe)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Kelloggs' Benelux (Belgium)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=16895884
Publication citations
-
Results
Eussen SJ, de Groot LC, Joosten LW, Bloo RJ, Clarke R, Ueland PM, Schneede J, Blom HJ, Hoefnagels WH, van Staveren WA, Effect of oral vitamin B-12 with or without folic acid on cognitive function in older people with mild vitamin B-12 deficiency: a randomized, placebo-controlled trial., Am. J. Clin. Nutr., 2006, 84, 2, 361-370.