Metanx Effects on Nerve Fiber Density in Neuropathic Diabetics (SLHN2011-18)
|ClinicalTrials.gov Identifier: NCT01503892|
Recruitment Status : Unknown
Verified July 2012 by Edwin S. Hart III, St. Luke's Hospital and Health Network, Pennsylvania.
Recruitment status was: Recruiting
First Posted : January 4, 2012
Last Update Posted : July 17, 2012
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Peripheral Neuropathy||Dietary Supplement: Metanx Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Metanx Effects on Nerve Fiber Density in Neuropathic Diabetics|
|Study Start Date :||December 2011|
|Estimated Primary Completion Date :||October 2013|
Placebo Comparator: Placebo
The control group will receive placebo pill twice daily for twelve months.
Placebo- one tablet twice daily for twelve months.
Active Comparator: Metanx
Metanx group will receive one pill twice daily for twelve months.
Dietary Supplement: Metanx
Metanx- one tablet twice daily for twelve months
- Increased intraepidermal nerve fiber density [ Time Frame: 1 year ]If Metanx® is able to reverse nerve damage and improve symptoms then the final nerve biopsies will show an increase in intraepidermal nerve fiber density
- Subjective improvement [ Time Frame: 1 year ]Improvement in the subjective score versus the placebo group.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01503892
|Contact: Edwin S. Hart III, DPMemail@example.com|
|United States, Pennsylvania|
|St. Luke's Hospital and Health Network||Recruiting|
|Bethlehem, Pennsylvania, United States, 18015|
|Contact: Edwin S. Hart III, DPM 610-868-4300 firstname.lastname@example.org|
|Principal Investigator:||Edwin S. Hart III, DPM||St. Luke's Hospital and Health Network|