Efficacy and Safety Study of Oral Eligen® B12 in Subjects With Low Serum Cobalamin

NCT01312831 | Completed

• 1 other identifier: EMIS-112-C-02
• Study Type: interventional
• Target: 49
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Vitamin B 12 Deficiency

Keywords

cobalamin; B12; homocysteine; MMA; holotranscobalamin; Eligen

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Maintenance of B12 Normalization

  91 days

• Time to Normalization

  90 days

• Percent Change from Baseline in Cobalamin Levels After 60 and 90 days of Treatment

  91 days

• Percent Change from Baseline in Methylmalonic Acid (MMA) Levels After 60 and 90 Days of Treatment

  91 days

• Percent Change from Baseline in Homocysteine Levels After 60 and 90 Days of Treatment

  91 days

Study Arms (2)

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.

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.

Other: Vitamin B12 (cyanocobalamin)

Interventions

Vitamin B12 (cyanocobalamin) OTHER

IM B12; Oral Eligen® B12

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Folate levels below the reference range provided by the clinical laboratory.
• Renal insufficiency
• Vitamin B6 deficiency

Sponsors & Collaborators

• Emisphere Technologies, Inc.: lead

Related Publications (1)

• 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.

  PMID: 21600388 DERIVED

MeSH Terms

Conditions

Vitamin B 12 Deficiency

Interventions

Vitamin B 12

Condition Hierarchy (Ancestors)

Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 4, 2011
• First Posted: March 11, 2011
• Study Start: February 1, 2009
• Study Completion: December 1, 2010
• Last Updated: March 11, 2011

Record last verified: 2011-03