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Completed

NCT Number: NCT01312831

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

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).

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Key information

Conditions

Vitamin B 12 Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Vitamin B Deficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin B12 (cyanocobalamin)

Other

Primary outcomes

  1. Serum Cobalamin Normalization

    Time frame: 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 outcomes

  1. Maintenance of B12 Normalization

    Time frame: 91 days

    Maintenance of cobalamin normalization after 90 days of treatment

  2. Time to Normalization

    Time frame: 90 days

    Time to normalization of cobalamin levels

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

    Time frame: 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.

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

    Time frame: 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)/B

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

    Time frame: 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)/B

  6. Number of Subjects with Adverse Events as a Measure of Safety and Tolerability

    Time frame: 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.

  7. Holo-trancobalamin (holo-TC) Normalization

    Time frame: 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

  8. Holo-TC and Cobalamin Correlation

    Time frame: 91 days

    Holo-TC levels in relation to cobalamin levels on Days 61 and 91 as an exploratory endpoint

Sponsors and collaborators

Lead sponsor

Emisphere Technologies, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2009
Study completion
2010
First posted
Mar 11, 2011
Registry last updated
Mar 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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