DementiaPhase 4NCT00164970
Can Oral Vitamin B12 and Folate Supplementation Preserve Cognitive Function of Patients With Early Dementia?
A Phase 4 study testing Vitamin B12 and folate in people with Dementia, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
Background: Vitamin B12 and folate are essential to brain health. Sub optimal status of vitamin B12 and folate leads to elevation of plasma homocysteine concentration, which is associated with Dementia. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- Vitamin B12 and folate
- How many people
- 166 participants
- Where
- 1 siteChina
- Study dates
- Oct 2004to Dec 2008
- Phase
- Phase 4
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Dementia of Alzheimer's or vascular type
- Early dementia defined by Clinical Dementia Rating of 1.
Who cannot join
- lives alone
- significant communication problems
- significant co-existing diseases
- blood tests:vitamin B12< 150 pmol/l, serum creatinine> 250 mol/l, hypothyroidism and syphilis
Trial locations and contacts
1 site in 1 country.
About this study
Background: Vitamin B12 and folate are essential to brain health. Sub optimal status of vitamin B12 and folate leads to elevation of plasma homocysteine concentration, which is associated with Dementia. Vitamin B12 and folate supplementation improved the cognitive function of demented subjects with hyperhomocysteinaemia in a pilot study.
Objective: To determine the effectiveness of vitamin B12 and folate supplementation in preserving cognitive function of subjects with early dementia
Read the detailed description
After stratified randomization by mini mental state examination scores, supplement group subjects take 1 mg of methylcobalamin and 5 mg of folic acid daily, while placebo group subjects take placebo capsules. The primary outcome is Mattis dementia rating scale. The secondary outcomes are mini mental state examination, neuropsychiatric inventory, and Cornell scale for depression in dementia. These measurements will be performed at baseline and every six months for 24 months. Fasting plasma homocysteine concentrations are measured at baseline and 18-month follow-up.
- Conditions
- Dementia
- Being tested
- Vitamin B12, folate
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin B12Dietary supplement
folateDietary supplement
What is being measured
The primary outcome is the main question the study is designed to answer.
dementia rating scale
Measured: at 6 months, 12 months and 18 months
depression rating scale
Measured: at 6 months, 12 months and 18 months
Secondary outcomes (3)
vitamin b12
Measured: at 18 months
folate
Measured: at 18 months
homocysteine
Measured: at 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Timothy CY Kwok, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00164970
- Sponsor's protocol ID
- RCT-B12
- Status last verified
- Feb 2009
- First submitted
- 12 Sep 2005
- Last updated
- 3 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Oral Vitamin B12 and Folate Supplementation Preserve Cognitive Function of Patients With Early Dementia?
- ClinicalTrials.gov ID
- NCT00164970
- Acronym / sponsor ID
- RCT-B12
- Conditions
- Dementia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 14 Sep 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.
Background: Vitamin B12 and folate are essential to brain health. Sub optimal status of vitamin B12 and folate leads to elevation of plasma homocysteine concentration, which is associated with Dementia. Vitamin B12 and folate supplementation improved the cognitive function of demented subjects with hyperhomocysteinaemia in a pilot study.
Objective: To determine the effectiveness of vitamin B12 and folate supplementation in preserving cognitive function of subjects with early dementia
Detailed description
After stratified randomization by mini mental state examination scores, supplement group subjects take 1 mg of methylcobalamin and 5 mg of folic acid daily, while placebo group subjects take placebo capsules. The primary outcome is Mattis dementia rating scale. The secondary outcomes are mini mental state examination, neuropsychiatric inventory, and Cornell scale for depression in dementia. These measurements will be performed at baseline and every six months for 24 months. Fasting plasma homocysteine concentrations are measured at baseline and 18-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Dementia of Alzheimer's or vascular type
- Early dementia defined by Clinical Dementia Rating of 1.
Key exclusion criteria (4 listed)
- lives alone
- significant communication problems
- significant co-existing diseases
- blood tests:vitamin B12< 150 pmol/l, serum creatinine> 250 mol/l, hypothyroidism and syphilis
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 | Dietary supplement | – |
| folate | Dietary supplement | – |
Primary outcome
dementia rating scale
Time frame: at 6 months, 12 months and 18 months
depression rating scale
Time frame: at 6 months, 12 months and 18 months
3 secondary outcomes
vitamin b12
Time frame: at 18 months
folate
Time frame: at 18 months
homocysteine
Time frame: at 18 months
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 3 Feb 2009.
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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.
Timothy CY Kwok, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin B12 and folate in people with Dementia, run by Chinese University of Hong Kong at 1 site in China.
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 2 inclusion and 4 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 3 Feb 2009. 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
dementia rating scale (time frame: at 6 months, 12 months and 18 months). The study lists 2 primary outcomes in all. 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 3 Feb 2009.