ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT00111267
Recruitment Status : Completed
First Posted : May 19, 2005
Last Update Posted : June 24, 2005
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Wageningen University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Cognitive Decline Cognitive Symptoms Behavioral: vitamin B12 supplementation Behavioral: vitamin B12 + folic acid combined supplementation Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Enrollment : 165 participants
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
Study Start Date : May 2003
Study Completion Date : January 2005

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00111267


Locations
Netherlands
Wageningen University
Wageningen, Gelderland, Netherlands, 6700 EV
Sponsors and Collaborators
Wageningen University
ZonMw: The Netherlands Organisation for Health Research and Development
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00111267     History of Changes
Other Study ID Numbers: P03.0277L
ZonMW 2100.0067
First Posted: May 19, 2005    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: May 2005

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

Additional relevant MeSH terms:
Cognitive Dysfunction
Neurobehavioral Manifestations
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Vitamins
 Folic Acid
Hydroxocobalamin
Vitamin B 12
Vitamin B Complex
Micronutrients
Growth Substances
Physiological Effects of Drugs
Hematinics