Metanx Effects on Nerve Fiber Density in Neuropathic Diabetics (SLHN2011-18)
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|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|
|Diabetes Peripheral Neuropathy||Dietary Supplement: Metanx Drug: Placebo|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01503892
|Contact: Edwin S. Hart III, DPMfirstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Edwin S. Hart III, DPM||St. Luke's Hospital and Health Network|