Vitamin B12 DeficiencyNCT01136512
Metformin Use and Vitamin B12 Deficiency
An observational study of Vitamin B12 Deficiency and Type 2 Diabetes Mellitus, run by Northwell Health at 1 site in United States.
Trial summary
The primary objective is to determine the incidence of Vitamin B12 deficiency in patients on metformin therapy for diabetes. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin B12 Deficiency, Type 2 Diabetes Mellitus
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Dec 2008
- Phase
- Observational
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Outpatient and hospitalized patients with type 2 diabetes mellitus
Inclusion Criteria:Age 20-80; diagnosed with type 2 diabetes for at least 30 days
Exclusion Criteria:known vitamin B12 or folate deficiency; pernicious anemia; on vitamin B12 therapy; hematological malignancy; methotrexate use; alcohol intake greater than two drinks per day; vegetarian diet; previous gastric surgery; inflammatory bowel disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Staten Island University Hospital
Staten Island, New York, 10305
About this study
The primary objective is to determine the incidence of Vitamin B12 deficiency in patients on metformin therapy for diabetes.
- Conditions
- Vitamin B12 Deficiency, Type 2 Diabetes Mellitus
- Keywords
- metformin, vitamin B12, type 2 diabetes, methylmalonic acid, deficiency
- Medical subject headings
- Vitamin B 12 Deficiency, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| metformin use | Patients with type 2 diabetes treated with metformin | |
| no metformin use | Patients with type 2 diabetes who are not being treated with metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin B12 level
Measured: Single point
Secondary outcomes (1)
methylmalonic acid
Measured: single point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startAug 2007
- 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 Vitamin B12 DeficiencyStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neil Cohen, M.D., Principal investigator, Staten Island University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01136512
- Sponsor's protocol ID
- 07040
- Status last verified
- Jul 2013
- First submitted
- 2 Jun 2010
- Last updated
- 31 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metformin Use and Vitamin B12 Deficiency
- ClinicalTrials.gov ID
- NCT01136512
- Acronym / sponsor ID
- 07040
- Conditions
- Vitamin B12 Deficiency, Type 2 Diabetes Mellitus
- Keywords
- metformin, vitamin B12, type 2 diabetes, methylmalonic acid, deficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 3 Jun 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.
The primary objective is to determine the incidence of Vitamin B12 deficiency in patients on metformin therapy for diabetes.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metformin use | – | –Patients with type 2 diabetes treated with metformin |
| no metformin use | – | –Patients with type 2 diabetes who are not being treated with metformin |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient and hospitalized patients with type 2 diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vitamin B12 level
Time frame: Single point
1 secondary outcome
methylmalonic acid
Time frame: single point
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 31 Jul 2013.
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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.
Neil Cohen, M.D. principal investigator
Staten Island University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin B12 Deficiency and Type 2 Diabetes Mellitus, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 31 Jul 2013. 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 United States. 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?
Vitamin B12 level (time frame: Single point). 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 31 Jul 2013.