Oral Vitamin B12 Supplementation and Cognitive Performance in Elderly People
Primary Purpose
Cognitive Decline, Cognitive Symptoms
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
vitamin B12 supplementation
vitamin B12 + folic acid combined supplementation
Sponsored by
About this trial
This is an interventional prevention trial for Cognitive Decline focused on measuring vitamin B12, cognitive function, oral supplementation, elderly
Eligibility 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
Sites / Locations
- Wageningen University
Outcomes
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
Full Information
NCT ID
NCT00111267
First Posted
May 18, 2005
Last Updated
June 23, 2005
Sponsor
Wageningen University
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT00111267
Brief Title
Oral Vitamin B12 Supplementation and Cognitive Performance in Elderly People
Official Title
The Effect of Oral Vitamin B12 Supplementation on Cognitive Performance in Elderly People: the Brain12 Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2005
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Wageningen University
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Decline, Cognitive Symptoms
Keywords
vitamin B12, cognitive function, oral supplementation, elderly
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
165 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
vitamin B12 supplementation
Intervention Type
Behavioral
Intervention Name(s)
vitamin B12 + folic acid combined supplementation
Primary Outcome Measure Information:
Title
Cognitive performance in the domains of attention, concentration, memory, executive function, speed
Secondary Outcome Measure Information:
Title
Blood biochemistry including vitamin B12, methylmalonic acid, holotranscobalamin, homocysteine, and red blood cell folate
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Wageningen University
City
Wageningen
State/Province
Gelderland
ZIP/Postal Code
6700 EV
Country
Netherlands
12. IPD Sharing Statement
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