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

NCT01312831 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2011-03-11

No results posted yet for this study

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).

Conditions

  • Vitamin B 12 Deficiency

Interventions

OTHER

Vitamin B12 (cyanocobalamin)

Sponsors & Collaborators

  • Emisphere Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Benno Roesch, MD · Frontage (formerly ABR), 241 Main Street, Hackensack, NJ 07601 USA

  • Nancy Allegar, MD · Alatae Medical LLC, 390 Amwell Road, Building 5, Hillsborough, NJ 08844 USA

  • Mitchell K. Spinnell, MD · Gastroenterology, 1555 Center Avenue, Fort Lee, NJ 07024 USA

  • Michael M. Rothkopf, MD · South Mountain Medical Consultants, 1500 Pleasant Valley Way, Suite 201, West Orange, NJ 07052 USA

  • Peter Varunok, MD · Gastroenterology Associates, 243 North Road, Suite 304, Poughkeepsie, NY 12601 USA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Completion
2010-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01312831 on ClinicalTrials.gov