Oral Vitamin B12 Supplementation and Cognitive Performance in Elderly People

This study has been completed.

Sponsor:

Collaborator:

ZonMw: The Netherlands Organisation for Health Research and Development

Information provided by:

Wageningen University

ClinicalTrials.gov Identifier:

NCT00111267

First received: May 18, 2005

Last updated: June 23, 2005

Last verified: May 2005

History of Changes

Tracking Information
First Received Date ^ICMJE	May 18, 2005
Last Updated Date	June 23, 2005
Start Date ^ICMJE	May 2003
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Cognitive performance in the domains of attention, concentration, memory, executive function, speed
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00111267 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 23, 2005)	Blood biochemistry including vitamin B12, methylmalonic acid, holotranscobalamin, homocysteine, and red blood cell folate
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Oral Vitamin B12 Supplementation and Cognitive Performance in Elderly People
Official Title ^ICMJE	The Effect of Oral Vitamin B12 Supplementation on Cognitive Performance in Elderly People: the Brain12 Study
Brief Summary	The purpose of this trial is to study the effects of oral vitamin B12 supplementation and vitamin B12 combined with folic acid supplementation on cognitive performance for 24 weeks in elderly people with mild vitamin B12 deficiency.
Detailed Description	Mild vitamin B12 deficiency is highly prevalent in old age. Reasons for this high prevalence are not fully understood, but include atrophic gastritis and bacterial overgrowth which affect the absorption (active) of food-bound vitamin B12. In contrast, the ability to absorb crystalline vitamin B12 (e.g. the form found in fortified foods or vitamin pills) remains intact in old age. In both healthy and cognitively impaired elderly people, associations between vitamin B12 status and cognitive performance have been observed, and the follow-up of geriatric patients suggests effects of parenteral treatment in early cognitive impairment. We investigated whether daily oral supplementation with 1,000 μg vitamin B12 or 1,000 μg vitamin B12 combined with 400 μg folate for 24 weeks improves cognitive performance in people over 70 years with vitamin B12 deficiency.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention
Condition ^ICMJE	Cognitive Decline Cognitive Symptoms
Intervention ^ICMJE	Behavioral: vitamin B12 supplementation Behavioral: vitamin B12 + folic acid combined supplementation
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	165
Completion Date	January 2005
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: Mild vitamin B12 deficiency: Low plasma vitamin B12 concentration (100 < B12 < 300 pmol/L) Elevated methylmalonic acid (MMA) concentration (> 0.32 umol/L) Creatinine concentration < 120 umol/L Exclusion Criteria: Severe cognitive impairment Anemia Gastrointestinal surgery or diseases Use of vitamin B12 injections or supplements containing > 25 ug vitamin B12 and/or 200 ug folic acid < 90% compliance during a 2 week placebo run in period No written informed consent Participation in other research studies
Gender	Both
Ages	70 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Netherlands

Administrative Information
NCT Number ^ICMJE	NCT00111267
Other Study ID Numbers ^ICMJE	P03.0277L, ZonMW 2100.0067
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Wageningen University
Collaborators ^ICMJE	ZonMw: The Netherlands Organisation for Health Research and Development
Investigators ^ICMJE	Not Provided
Information Provided By	Wageningen University
Verification Date	May 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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