Cognitive DeclineNCT00111267
Oral Vitamin B12 Supplementation and Cognitive Performance in Elderly People
A study testing vitamin B12 supplementation and vitamin B12 + folic acid combined supplementation in people with Cognitive Decline and Cognitive Symptoms, run by Wageningen University at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline, Cognitive Symptoms
- What is being tested?
- vitamin B12 supplementation and vitamin B12 + folic acid combined supplementation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 165 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2003to Jan 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cognitive Decline, Cognitive Symptoms
- Being tested
- vitamin B12 supplementation, vitamin B12 + folic acid combined supplementation
- Keywords
- vitamin B12, cognitive function, oral supplementation, elderly
- Medical subject headings
- Cognitive Dysfunction, Neurobehavioral Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin B12 supplementationBehavioural
vitamin B12 + folic acid combined supplementationBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive performance in the domains of attention, concentration, memory, executive function, speed
Secondary outcomes (1)
Blood biochemistry including vitamin B12, methylmalonic acid, holotranscobalamin, homocysteine, and red blood cell folate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2005 (estimated)
- Study startMay 2003
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 165 participants
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00111267
- Sponsor's protocol ID
- P03.0277L
- Other IDs
- ZonMW 2100.0067
- Status last verified
- May 2005
- First submitted
- 18 May 2005
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Vitamin B12 Supplementation on Cognitive Performance in Elderly People: the Brain12 Study
- ClinicalTrials.gov ID
- NCT00111267
- Acronym / sponsor ID
- P03.0277L
- Conditions
- Cognitive Decline, Cognitive Symptoms
- Keywords
- vitamin B12, cognitive function, oral supplementation, elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- May 2003
- Study completion
- Jan 2005
- First posted
- 19 May 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Mild vitamin B12 deficiency:
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitamin B12 supplementation | Behavioural | – |
| vitamin B12 + folic acid combined supplementation | Behavioural | – |
Primary outcome
Cognitive performance in the domains of attention, concentration, memory, executive function, speed
1 secondary outcome
Blood biochemistry including vitamin B12, methylmalonic acid, holotranscobalamin, homocysteine, and red blood cell folate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitamin B12 supplementation and vitamin B12 + folic acid combined supplementation in people with Cognitive Decline and Cognitive Symptoms, run by Wageningen University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive performance in the domains of attention, concentration, memory, executive function, speed. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.