Cognitive FunctionNCT01095211
B-vitamins Treatment for Improvement of Cognitive Function
A study testing B-vitamin complex in people with Cognitive Function and Metabolic Improvements, run by Universität des Saarlandes at 1 site in Germany.
Trial summary
Observation studies documented a correlation between plasma concentrations of homocysteine and cognitive decline with age. The study hypothesis was that high doses of B-vitamins (as effective homocysteine lowering treatment) can improve cognitive function in elderly people. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cognitive Function, Metabolic Improvements
- What is being tested?
- B-vitamin complex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2003to Dec 2009
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- age > 65 years and glomerular filtration rate (GFR) > 35 ml/min
Who cannot join
- acute cancer or those who had coronary or cerebral event or thrombosis in the last 3 months were not eligible for the study.
- furthermore, people who had dementia (mini-mental state-examination scores MMSE < 15)
- those treated with B-vitamins
- those with renal insufficiency
- those receiving drugs that affect Hcy-metabolism (methotrexate, anti-epileptics, L-dopa) were not allowed to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of B-Vitamins on Cognitive Function in Elderly People
Observation studies documented a correlation between plasma concentrations of homocysteine and cognitive decline with age. The study hypothesis was that high doses of B-vitamins (as effective homocysteine lowering treatment) can improve cognitive function in elderly people.
Read the detailed description
We performed a treatment with therapeutic doses of B-vitamins (folic acid, cobalamin, vitamin B6) for 45 days. We collected blood and tested the concentrations of the metabolic markers in blood at start, 3 weeks later and at the end. Cognitive function was tested at start and at the end.
- Conditions
- Cognitive Function, Metabolic Improvements
- Being tested
- B-vitamin complex
- Keywords
- folic acid, homocysteine, MMSE scores, methyl malonic acid, betaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B-vitamin complexDrug
Also called no other names
5 mg Folic acid, plus 1 mg cyanocobalamin and 40 mg vitamin B6) oral/ day. The placebo capsule contained 400 mg of mannitol: aerosil (99.5: 0.5). In addition, 1 mg/s.c cyanocobalamin daily
| Study group | Role | What they receive |
|---|---|---|
| B-Vitamins | Active comparator | folic acid, cobalamin, vitamin B6 Receives: Drug: B-vitamin complex |
| placebo | Placebo comparator | none of the vitamins (99.5% mannitol) Receives: Drug: B-vitamin complex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function
Measured: baseline and 45 days later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2010 (estimated)
- Study startJan 2003
- Primary completionSep 2005
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive FunctionStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität des Saarlandes
- Sponsor type
- University, hospital or other
- Collaborators
- Geriatrische Rehaklinik
- Investigators
- Rima Obeid, Principal investigator, Department of Clinical Chemistry, University of Saarland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01095211
- Sponsor's protocol ID
- Elderly St.Ingbert
- Status last verified
- May 2018
- First submitted
- 29 Mar 2010
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of B-Vitamins on Cognitive Function in Elderly People
- ClinicalTrials.gov ID
- NCT01095211
- Acronym / sponsor ID
- Elderly St.Ingbert
- Conditions
- Cognitive Function, Metabolic Improvements
- Keywords
- folic acid, homocysteine, MMSE scores, methyl malonic acid, betaine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Universität des SaarlandesUniversity, hospital or other
- Collaborators
- Geriatrische Rehaklinik
- Study start
- Jan 2003
- Primary completion
- Sep 2005 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 30 Mar 2010 (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.
Observation studies documented a correlation between plasma concentrations of homocysteine and cognitive decline with age. The study hypothesis was that high doses of B-vitamins (as effective homocysteine lowering treatment) can improve cognitive function in elderly people.
Detailed description
We performed a treatment with therapeutic doses of B-vitamins (folic acid, cobalamin, vitamin B6) for 45 days. We collected blood and tested the concentrations of the metabolic markers in blood at start, 3 weeks later and at the end. Cognitive function was tested at start and at the end.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B-Vitamins | Active comparator | Drug: B-vitamin complexfolic acid, cobalamin, vitamin B6 |
| placebo | Placebo comparator | Drug: B-vitamin complexnone of the vitamins (99.5% mannitol) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- age > 65 years and glomerular filtration rate (GFR) > 35 ml/min
Key exclusion criteria (5 listed)
- acute cancer or those who had coronary or cerebral event or thrombosis in the last 3 months were not eligible for the study.
- furthermore, people who had dementia (mini-mental state-examination scores MMSE < 15)
- those treated with B-vitamins
- those with renal insufficiency
- those receiving drugs that affect Hcy-metabolism (methotrexate, anti-epileptics, L-dopa) were not allowed to participate
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 |
|---|---|---|
| B-vitamin complexAlso: no other names5 mg Folic acid, plus 1 mg cyanocobalamin and 40 mg vitamin B6) oral/ day. The placebo capsule contained 400 mg of mannitol: aerosil (99.5: 0.5). In addition, 1 mg/s.c cyanocobalamin daily | Drug | B-Vitamins, placebo |
Primary outcome
Cognitive function
Time frame: baseline and 45 days later
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 11 May 2018.
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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.
Rima Obeid principal investigator
Department of Clinical Chemistry, University of Saarland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B-vitamin complex in people with Cognitive Function and Metabolic Improvements, run by Universität des Saarlandes at 1 site in Germany.
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 1 inclusion and 5 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 11 May 2018. 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 Germany. 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. Some participants in this study may receive a placebo. 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 function (time frame: baseline and 45 days later). 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 11 May 2018.