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Oral Vitamin B12 Supplementation and Cognitive Performance in Elderly People

This study has been completed.
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Wageningen University Identifier:
First received: May 18, 2005
Last updated: June 23, 2005
Last verified: May 2005
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.

Condition Intervention
Cognitive Decline Cognitive Symptoms Behavioral: vitamin B12 supplementation Behavioral: vitamin B12 + folic acid combined supplementation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: The Effect of Oral Vitamin B12 Supplementation on Cognitive Performance in Elderly People: the Brain12 Study

Resource links provided by NLM:

Further study details as provided by Wageningen University:

Primary Outcome Measures:
  • Cognitive performance in the domains of attention, concentration, memory, executive function, speed

Secondary Outcome Measures:
  • Blood biochemistry including vitamin B12, methylmalonic acid, holotranscobalamin, homocysteine, and red blood cell folate

Estimated Enrollment: 165
Study Start Date: May 2003
Estimated Study Completion Date: January 2005
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.


Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00111267

Wageningen University
Wageningen, Gelderland, Netherlands, 6700 EV
Sponsors and Collaborators
Wageningen University
ZonMw: The Netherlands Organisation for Health Research and Development
  More Information Identifier: NCT00111267     History of Changes
Other Study ID Numbers: P03.0277L
ZonMW 2100.0067
Study First Received: May 18, 2005
Last Updated: June 23, 2005

Keywords provided by Wageningen University:
vitamin B12
cognitive function
oral supplementation

Additional relevant MeSH terms:
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Folic Acid
Vitamin B 12
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Hematinics processed this record on September 21, 2017