Clinical trial NCT01312831: Efficacy and Safety Study of Oral Eligen® B12 in Subjects With Low Serum Cobalamin
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin B 12 Deficiency
Keywords: cobalamin
B12
homocysteine
MMA
holotranscobalamin
Eligen
Lead sponsor: Emisphere Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2011-03-11
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Serum Cobalamin Normalization
timeFrame: 61 days
Secondary outcomes:
measure: Maintenance of B12 Normalization
timeFrame: 91 days
measure: Time to Normalization
timeFrame: 90 days
measure: Percent Change from Baseline in Cobalamin Levels After 60 and 90 days of Treatment
timeFrame: 91 days
measure: Percent Change from Baseline in Methylmalonic Acid (MMA) Levels After 60 and 90 Days of Treatment
timeFrame: 91 days
measure: Percent Change from Baseline in Homocysteine Levels After 60 and 90 Days of Treatment
timeFrame: 91 days
measure: Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 91 days
measure: Holo-trancobalamin (holo-TC) Normalization
timeFrame: 91 days
measure: Holo-TC and Cobalamin Correlation
timeFrame: 91 days
Other outcomes:
Locations:
Study officials:
affiliation: Frontage (formerly ABR), 241 Main Street, Hackensack, NJ 07601 USA
name: Benno Roesch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alatae Medical LLC, 390 Amwell Road, Building 5, Hillsborough, NJ 08844 USA
name: Nancy Allegar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gastroenterology, 1555 Center Avenue, Fort Lee, NJ 07024 USA
name: Mitchell K. Spinnell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: South Mountain Medical Consultants, 1500 Pleasant Valley Way, Suite 201, West Orange, NJ 07052 USA
name: Michael M. Rothkopf, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gastroenterology Associates, 243 North Road, Suite 304, Poughkeepsie, NY 12601 USA
name: Peter Varunok, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.