- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00111267
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Gelderland
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Wageningen, Gelderland, Netherlands, 6700 EV
- Wageningen University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Cognitive performance in the domains of attention, concentration, memory, executive function, speed
|
Secondary Outcome Measures
Outcome Measure |
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Blood biochemistry including vitamin B12, methylmalonic acid, holotranscobalamin, homocysteine, and red blood cell folate
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P03.0277L
- ZonMW 2100.0067
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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