Vitamin B 12 DeficiencyNCT01312831
Efficacy and Safety Study of Oral Eligen® B12 in Subjects With Low Serum Cobalamin
A study testing Vitamin B12 (cyanocobalamin) in people with Vitamin B 12 Deficiency, run by Emisphere Technologies, Inc..
Trial summary
The purpose of this study is to compare the efficacy and safety profile of a new oral vitamin B12 formulation (Eligen® B12) with intramuscular B12 in restoring normal B12 (cobalamin) concentrations in subjects with low cobalamin levels (<350 pg/mL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitamin B 12 Deficiency
- What is being tested?
- Vitamin B12 (cyanocobalamin)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to Dec 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Vitamin B12 deficiency defined as serum cobalamin below 350 pg/mL
- Age 60 or older; or age 18 or older with gastrointestinal abnormalities including but not limited to gastrointestinal surgery (e.g. gastrectomy, gastric bypass), ileal resection, gastric atrophy, Celiac disease, Crohn's disease, or prolonged use (>3 months) of proton pump inhibitor drugs, or on a restricted diet (such as vegetarian or vegan).
- General good health, as indicated by lack of significant findings in medical history, physical examination, clinical laboratory tests (chemistry, hematology and urinalysis), vital signs, ECG and normal kidney function as determined by estimated creatinine clearance computed with the Cockcroft and Gault formula
Who cannot join
- Current treatment from a health care provider to treat vitamin B12 deficiency and/or symptoms;
- Daily use of neutralizing antacids (e.g. Maalox®)
- Inability to ingest oral medication
- Clinically significant laboratory value at screening
- Hypersensitivity or allergic reaction to vitamin B12
- Participation in a clinical research study involving a new chemical entity within 30 days of the first study dose
Show all 9Show fewer
- Folate levels below the reference range provided by the clinical laboratory.
- Renal insufficiency
- Vitamin B6 deficiency
About this study
Official title: A 60-DAY, Open-label, Randomized Study to Evaluate the Efficacy and Safety of Eligen® B12 OR Intramuscularly Administered B12 in Subjects With Low Serum Cobalamin With a 30 Day Extension to 90 Days of Dosing
The purpose of this study is to compare the efficacy and safety profile of a new oral vitamin B12 formulation (Eligen® B12) with intramuscular B12 in restoring normal B12 (cobalamin) concentrations in subjects with low cobalamin levels (<350 pg/mL).
- Conditions
- Vitamin B 12 Deficiency
- Being tested
- Vitamin B12 (cyanocobalamin)
- Keywords
- cobalamin, B12, homocysteine, MMA, holotranscobalamin, Eligen
- Medical subject headings
- Vitamin B 12 Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin B12 (cyanocobalamin)Other
| Study group | Role | What they receive |
|---|---|---|
| Oral Eligen® B12 | Experimental | Eligen® B12 1000 μg oral tablet taken in the fasted state as a single tablet with 50 mL water. Each dose self-administered daily, for 90 days, after an overnight fast and 1 hour before the morning meal. Receives: Other: Vitamin B12 (cyanocobalamin) |
| IM B12 | Active comparator | Commercially available 1000 μg cyanocobalamin administered IM as 1 mL from a vial containing 1000 μg/mL drug administered by study personnel, in the research clinic, in the morning, in the fasted state and at least 1 hour prior to the morning meal on study Days 1, 3, 7, 10, 14, 21, 30, 60 and 90. Receives: Other: Vitamin B12 (cyanocobalamin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Cobalamin Normalization
The primary efficacy outcome compares the proportion of subjects in each treatment arm in whom cobalamin levels are normalized (i.e., cobalamin ≥ 350 ng/mL) following 60 days of treatment
Measured: 61 days
Secondary outcomes (8)
Maintenance of B12 Normalization
Maintenance of cobalamin normalization after 90 days of treatment
Measured: 91 days
Time to Normalization
Time to normalization of cobalamin levels
Measured: 90 days
Percent Change from Baseline in Cobalamin Levels After 60 and 90 days of Treatment
Change from baseline is defined as (X-B) where B is the baseline (pre-dose Day 1) measurement of cobalamin (pg/mL) and X is the measurement of cobalamin(pg/mL) at Day 61 or Day 91, as required.
Percent change from baseline is defined as 100(X-B)/B.
Measured: 91 days
Percent Change from Baseline in Methylmalonic Acid (MMA) Levels After 60 and 90 Days of Treatment
Change from baseline is defined as (X-B) where B is the baseline (pre-dose Day 1) measurement of MMA (ng/mL) and X is the measurement of MMA (ng/mL) at Day 61 or Day 91, as required.
Percent change from baseline is defined as 100(X-B)/B
Measured: 91 days
Percent Change from Baseline in Homocysteine Levels After 60 and 90 Days of Treatment
Change from baseline is defined as (X-B) where B is the baseline (pre-dose Day 1) measurement of homocysteine (umol/L) and X is the measurement of homocysteine (umol/L) at Day 61 or Day 91, as required.
Percent change from baseline is defined as 100(X-B)/B
Measured: 91 days
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
The safety and tolerability of Eligen® B12 and intramuscular B12 assessed by physical examination findings, clinical laboratory test results, vital signs, 12-lead ECG results and adverse event reporting.
Measured: 91 days
Holo-trancobalamin (holo-TC) Normalization
The proportion of subjects who achieve normalization of holo-TC levels (≥ 40 pmol/L) on Days 61 and 91 as an exploratory endpoint
Measured: 91 days
Holo-TC and Cobalamin Correlation
Holo-TC levels in relation to cobalamin levels on Days 61 and 91 as an exploratory endpoint
Measured: 91 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2011 (estimated)
- Study startFeb 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin B 12 DeficiencyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emisphere Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Benno Roesch, MD, Principal investigator, Frontage (formerly ABR), 241 Main Street, Hackensack, NJ 07601 USANancy Allegar, MD, Principal investigator, Alatae Medical LLC, 390 Amwell Road, Building 5, Hillsborough, NJ 08844 USAMitchell K. Spinnell, MD, Principal investigator, Gastroenterology, 1555 Center Avenue, Fort Lee, NJ 07024 USAMichael M. Rothkopf, MD, Principal investigator, South Mountain Medical Consultants, 1500 Pleasant Valley Way, Suite 201, West Orange, NJ 07052 USAPeter Varunok, MD, Principal investigator, Gastroenterology Associates, 243 North Road, Suite 304, Poughkeepsie, NY 12601 USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312831
- Sponsor's protocol ID
- EMIS-112-C-02
- Status last verified
- Mar 2011
- First submitted
- 4 Mar 2011
- Last updated
- 11 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Castelli MC, Friedman K, Sherry J, Brazzillo K, Genoble L, Bhargava P, Riley MG. Comparing the efficacy and tolerability of a new daily oral vitamin B12 formulation and intermittent intramuscular vitamin B12 in normalizing low cobalamin levels: a randomized, open-label, parallel-group study. Clin Ther. 2011 Mar;33(3):358-371.e2. doi: 10.1016/j.clinthera.2011.03.003.
PubMed 21600388
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 60-DAY, Open-label, Randomized Study to Evaluate the Efficacy and Safety of Eligen® B12 OR Intramuscularly Administered B12 in Subjects With Low Serum Cobalamin With a 30 Day Extension to 90 Days of Dosing
- ClinicalTrials.gov ID
- NCT01312831
- Acronym / sponsor ID
- EMIS-112-C-02
- Conditions
- Vitamin B 12 Deficiency
- Keywords
- cobalamin, B12, homocysteine, MMA, holotranscobalamin, Eligen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Emisphere Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2009
- Study completion
- Dec 2010 (actual)
- First posted
- 11 Mar 2011 (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 study is to compare the efficacy and safety profile of a new oral vitamin B12 formulation (Eligen® B12) with intramuscular B12 in restoring normal B12 (cobalamin) concentrations in subjects with low cobalamin levels (<350 pg/mL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Eligen® B12 | Experimental | Other: Vitamin B12 (cyanocobalamin)Eligen® B12 1000 μg oral tablet taken in the fasted state as a single tablet with 50 mL water. Each dose self-administered daily, for 90 days, after an overnight fast and 1 hour before the morning meal. |
| IM B12 | Active comparator | Other: Vitamin B12 (cyanocobalamin)Commercially available 1000 μg cyanocobalamin administered IM as 1 mL from a vial containing 1000 μg/mL drug administered by study personnel, in the research clinic, in the morning, in the fasted state and at least 1 hour prior to the morning meal on study Days 1, 3, 7, 10, 14, 21, 30, 60 and 90. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Vitamin B12 deficiency defined as serum cobalamin below 350 pg/mL
- Age 60 or older; or age 18 or older with gastrointestinal abnormalities including but not limited to gastrointestinal surgery (e.g. gastrectomy, gastric bypass), ileal resection, gastric atrophy, Celiac disease, Crohn's disease, or prolonged use (>3 months) of proton pump inhibitor drugs, or on a restricted diet (such as vegetarian or vegan).
- General good health, as indicated by lack of significant findings in medical history, physical examination, clinical laboratory tests (chemistry, hematology and urinalysis), vital signs, ECG and normal kidney function as determined by estimated creatinine clearance computed with the Cockcroft and Gault formula
Key exclusion criteria (9 listed)
- Current treatment from a health care provider to treat vitamin B12 deficiency and/or symptoms;
- Daily use of neutralizing antacids (e.g. Maalox®)
- Inability to ingest oral medication
- Clinically significant laboratory value at screening
- Hypersensitivity or allergic reaction to vitamin B12
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 (cyanocobalamin) | Other | IM B12, Oral Eligen® B12 |
Primary outcome
Serum Cobalamin Normalization
Time frame: 61 days
The primary efficacy outcome compares the proportion of subjects in each treatment arm in whom cobalamin levels are normalized (i.e., cobalamin ≥ 350 ng/mL) following 60 days of treatment
8 secondary outcomes
Maintenance of B12 Normalization
Time frame: 91 days
Time to Normalization
Time frame: 90 days
Percent Change from Baseline in Cobalamin Levels After 60 and 90 days of Treatment
Time frame: 91 days
Percent Change from Baseline in Methylmalonic Acid (MMA) Levels After 60 and 90 Days of Treatment
Time frame: 91 days
Percent Change from Baseline in Homocysteine Levels After 60 and 90 Days of Treatment
Time frame: 91 days
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
Time frame: 91 days
Holo-trancobalamin (holo-TC) Normalization
Time frame: 91 days
Holo-TC and Cobalamin Correlation
Time frame: 91 days
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 Mar 2011.
- Derived from this study: PubMed 21600388Castelli MC, Friedman K, Sherry J, Brazzillo K, Genoble L, Bhargava P, Riley MG. Comparing the efficacy and tolerability of a new daily oral vitamin B12 formulation and intermittent intramuscular vitamin B12 in normalizing low cobalamin levels: a randomized, open-label, parallel-group study. Clin Ther. 2011 Mar;33(3):358-371.e2. doi: 10.1016/j.clinthera.2011.03.003.
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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.
Benno Roesch, MD principal investigator
Frontage (formerly ABR), 241 Main Street, Hackensack, NJ 07601 USA
Nancy Allegar, MD principal investigator
Alatae Medical LLC, 390 Amwell Road, Building 5, Hillsborough, NJ 08844 USA
Mitchell K. Spinnell, MD principal investigator
Gastroenterology, 1555 Center Avenue, Fort Lee, NJ 07024 USA
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin B12 (cyanocobalamin) in people with Vitamin B 12 Deficiency, run by Emisphere Technologies, Inc..
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 3 inclusion and 9 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 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Serum Cobalamin Normalization (time frame: 61 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01312831, which also lists 1 linked publication.
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 Mar 2011.