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Study of Metanx® in Subjects With Type 2 Diabetic Peripheral Neuropathy (DPN)

NCT00726713 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2013-08-30

Study results available
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Summary

The purpose of this research study is to determine if Metanx improves sensory neuropathy in persons with Type 2 diabetes. Metanx is a medical food available with a prescription from a physician. It consists of L-methylfolate, Pyridoxal 5'-phosphate, and Methylcobalamin, which are the active forms of folate, vitamin B6, and vitamin B12, respectively. Subjects will be randomly assigned to receive either Metanx or placebo for 6 months.

Conditions

  • Type 2 Diabetic Peripheral Neuropathy (DPN)

Interventions

OTHER

Metanx (a medical food)

Metanx one tablet twice a day

OTHER

Metanx placebo

Metanx placebo one tablet twice a day

Sponsors & Collaborators

  • Tulane University Health Sciences Center

    collaborator OTHER

  • VA Nebraska Western Iowa Health Care System

    collaborator FED

  • Scott and White Hospital & Clinic

    collaborator OTHER

  • Dallas Diabetes and Endocrine Center

    collaborator OTHER

  • University of Alabama at Birmingham

    collaborator OTHER

  • dgd Research, Inc.

    collaborator INDUSTRY

  • Baylor Health Care System

    collaborator OTHER

  • Pamlab, Inc.

    lead INDUSTRY

Principal Investigators

  • Vivian Fonseca, MD · Tulane University Health Sciences Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2010-05-31
Completion
2011-06-30

Countries

  • United States

Study Locations

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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 NCT00726713 on ClinicalTrials.gov