Efficacy and Safety Study of Oral Eligen® B12 in Subjects With Low Serum Cobalamin
- Conditions
- Vitamin B 12 Deficiency
- Registration Number
- NCT01312831
- Lead Sponsor
- Emisphere Technologies, Inc.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Serum Cobalamin Normalization 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
- Secondary Outcome Measures
Name Time Method Maintenance of B12 Normalization 91 days Maintenance of cobalamin normalization after 90 days of treatment
Time to Normalization 90 days Time to normalization of cobalamin levels
Percent Change from Baseline in Cobalamin Levels After 60 and 90 days of Treatment 91 days 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.Percent Change from Baseline in Methylmalonic Acid (MMA) Levels After 60 and 90 Days of Treatment 91 days 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)/BPercent Change from Baseline in Homocysteine Levels After 60 and 90 Days of Treatment 91 days 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)/BNumber of Subjects with Adverse Events as a Measure of Safety and Tolerability 91 days 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.
Holo-trancobalamin (holo-TC) Normalization 91 days The proportion of subjects who achieve normalization of holo-TC levels (≥ 40 pmol/L) on Days 61 and 91 as an exploratory endpoint
Holo-TC and Cobalamin Correlation 91 days Holo-TC levels in relation to cobalamin levels on Days 61 and 91 as an exploratory endpoint