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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
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
Time frame: 61 days
Maintenance of B12 Normalization
Maintenance of cobalamin normalization after 90 days of treatment
Time frame: 91 days
Time to Normalization
Time to normalization of cobalamin levels
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 91 days
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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.
Time frame: 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
Time frame: 91 days
Holo-TC and Cobalamin Correlation
Holo-TC levels in relation to cobalamin levels on Days 61 and 91 as an exploratory endpoint
Time frame: 91 days