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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
Sponsor:
Collaborators:
Information provided by (Responsible Party):

December 29, 2011
January 4, 2012
July 17, 2012
December 2011
October 2013   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01503892 on ClinicalTrials.gov Archive Site
Subjective improvement [ Time Frame: 1 year ]
Improvement in the subjective score versus the placebo group.
Same as current
Not Provided
Not Provided
 
Metanx Effects on Nerve Fiber Density in Neuropathic Diabetics
Metanx Effects on Nerve Fiber Density in Neuropathic Diabetics
This study focuses on the use of Metanx® as the sole treatment for improving and reversing nerve damage in type 2 diabetic patients with peripheral neuropathy. There will be two equal study groups enrolled in this randomized double blinded study. The minimum sample size of enrollment is 24 (12 per group), which is required for 90% power at alpha = .05. The maximum number of participants will be set at 100 (50 per group). Patients who are pre-diabetic or patients who have been diagnosed with diabetes type II for less than five years are included in this study. The control group will receive placebo pill twice daily versus the treatment group which will receive one Metanx® tablet twice daily. Each group will have intraepidermal nerve fiber densities obtained by skin biopsies taken at the beginning of the study before any treatment has begun as well as a final intraepidermal nerve skin biopsy at the end of twelve months to re-biopsy. In addition each group will answer three sets of questionnaires relating to their peripheral neuropathy at initial, three months, twelve month visitations. 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 and an improvement in the subjective score versus the placebo group.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Diabetes
  • Peripheral Neuropathy
  • Dietary Supplement: Metanx
    Metanx- one tablet twice daily for twelve months
  • Drug: Placebo
    Placebo- one tablet twice daily for twelve months.
  • Placebo Comparator: Placebo
    The control group will receive placebo pill twice daily for twelve months.
    Intervention: Drug: Placebo
  • Active Comparator: Metanx
    Metanx group will receive one pill twice daily for twelve months.
    Intervention: Dietary Supplement: Metanx
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
100
Not Provided
October 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 Diabetics
  • Pre-diabetics
  • Symptoms of peripheral neuropathy

Exclusion Criteria:

  • Pregnancy
  • Under age 18
  • HIV (+)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01503892
StLukeHHN
Yes
Not Provided
Not Provided
Edwin S. Hart III, St. Luke's Hospital and Health Network, Pennsylvania
St. Luke's Hospital and Health Network, Pennsylvania
  • Goldfarb Foundation
  • Pamlab, L.L.C.
Principal Investigator: Edwin S. Hart III, DPM St. Luke's Hospital and Health Network
St. Luke's Hospital and Health Network, Pennsylvania
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP