Oral Vitamin B12 Supplementation and Cognitive Performance in Elderly People

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00111267
Recruitment Status : Completed
First Posted : May 19, 2005
Last Update Posted : June 24, 2005
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Wageningen University

May 18, 2005
May 19, 2005
June 24, 2005
May 2003
Not Provided
Cognitive performance in the domains of attention, concentration, memory, executive function, speed
Same as current
No Changes Posted
Blood biochemistry including vitamin B12, methylmalonic acid, holotranscobalamin, homocysteine, and red blood cell folate
Same as current
Not Provided
Not Provided
Oral Vitamin B12 Supplementation and Cognitive Performance in Elderly People
The Effect of Oral Vitamin B12 Supplementation on Cognitive Performance in Elderly People: the Brain12 Study
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.

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.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
  • Cognitive Decline
  • Cognitive Symptoms
  • Behavioral: vitamin B12 supplementation
  • Behavioral: vitamin B12 + folic acid combined supplementation
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
January 2005
Not Provided

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
Sexes Eligible for Study: All
70 Years and older   (Senior)
Contact information is only displayed when the study is recruiting subjects
ZonMW 2100.0067
Not Provided
Not Provided
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Wageningen University
ZonMw: The Netherlands Organisation for Health Research and Development
Not Provided
Wageningen University
May 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP