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The Nutritional Benefits of Metanx in Patients With Diabetic Peripheral Neuropathy (MEDIAN)

NCT01990092 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 238

Last updated 2016-01-18

No results posted yet for this study

Summary

The objectives of the MEDIAN study are to evaluate the short-term and long-term safety and nutritional benefits of Metanx® versus placebo in subjects with mild to moderate diabetic peripheral neuropathy (DPN). Short-term effects will be evaluated during the first 16 weeks of treatment, and long-term effects will be evaluated over the duration of a 48 week treatment period.

Conditions

  • Diabetic Peripheral Neuropathy
  • B Vitamin Deficiency

Interventions

OTHER

Metanx

Metanx is a prescription medical food.

OTHER

Placebo

Sponsors & Collaborators

  • Pamlab, Inc.

    lead INDUSTRY

Principal Investigators

  • Roy Freeman, MD · Beth Israel Deaconess Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2016-08-31
Completion
2018-03-31

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 NCT01990092 on ClinicalTrials.gov