Condition category
Nutritional, Metabolic, Endocrine
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
09/11/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

Cognitive performance.

Secondary outcome measures

Blood biochemistry.

Overall trial start date

01/05/2003

Overall trial end date

31/10/2004

Reason abandoned

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

http://www.zonmw.nl

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

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=16895884

Publication citations

  1. 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.

Additional files

Editorial Notes