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

Emisphere Technologies

Status: Completed

Conditions: Vitamin B 12 Deficiency

Treatments: Other: Vitamin B12 (cyanocobalamin)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01312831

EMIS-112-C-02

Details and patient eligibility

About

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).

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Oral Eligen® B12

Experimental group

Description:

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.

Treatment:

Other: Vitamin B12 (cyanocobalamin)

IM B12

Active Comparator group

Description:

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.

Treatment:

Other: Vitamin B12 (cyanocobalamin)