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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin B12 (cyanocobalamin) | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 61 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maintenance of B12 Normalization | Maintenance of cobalamin normalization after 90 days of treatment | 91 days |
| Time to Normalization | Time to normalization of cobalamin levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benno Roesch, MD | Frontage (formerly ABR), 241 Main Street, Hackensack, NJ 07601 USA | Principal Investigator |
| Nancy Allegar, MD | Alatae Medical LLC, 390 Amwell Road, Building 5, Hillsborough, NJ 08844 USA | Principal Investigator |
| Mitchell K. Spinnell, MD | Gastroenterology, 1555 Center Avenue, Fort Lee, NJ 07024 USA | Principal Investigator |
| Michael M. Rothkopf, MD | South Mountain Medical Consultants, 1500 Pleasant Valley Way, Suite 201, West Orange, NJ 07052 USA | Principal Investigator |
| Peter Varunok, MD | Gastroenterology Associates, 243 North Road, Suite 304, Poughkeepsie, NY 12601 USA | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21600388 | Derived | 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. |
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| ID | Term |
|---|---|
| D014806 | Vitamin B 12 Deficiency |
| ID | Term |
|---|---|
| D014804 | Vitamin B Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
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| ID | Term |
|---|---|
| D014805 | Vitamin B 12 |
| ID | Term |
|---|---|
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 |
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| 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. | 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 | 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 | 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. | 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 | 91 days |
| Holo-TC and Cobalamin Correlation | Holo-TC levels in relation to cobalamin levels on Days 61 and 91 as an exploratory endpoint | 91 days |
| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |