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Metanx Effects on Nerve Fiber Density in Neuropathic Diabetics (SLHN2011-18)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Goldfarb Foundation
Pamlab, L.L.C.
Information provided by (Responsible Party):
Edwin S. Hart III, St. Luke's Hospital and Health Network, Pennsylvania

Tracking Information
First Submitted Date  ICMJE December 29, 2011
First Posted Date  ICMJE January 4, 2012
Last Update Posted Date July 17, 2012
Study Start Date  ICMJE December 2011
Estimated Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 31, 2011)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 31, 2011)
Subjective improvement [ Time Frame: 1 year ]
Improvement in the subjective score versus the placebo group.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Metanx Effects on Nerve Fiber Density in Neuropathic Diabetics
Official Title  ICMJE Metanx Effects on Nerve Fiber Density in Neuropathic Diabetics
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Peripheral Neuropathy
Intervention  ICMJE
  • Dietary Supplement: Metanx
    Metanx- one tablet twice daily for twelve months
  • Drug: Placebo
    Placebo- one tablet twice daily for twelve months.
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 31, 2011)
100
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • Under age 18
  • HIV (+)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01503892
Other Study ID Numbers  ICMJE StLukeHHN
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Edwin S. Hart III, St. Luke's Hospital and Health Network, Pennsylvania
Study Sponsor  ICMJE St. Luke's Hospital and Health Network, Pennsylvania
Collaborators  ICMJE
  • Goldfarb Foundation
  • Pamlab, L.L.C.
Investigators  ICMJE
Principal Investigator: Edwin S. Hart III, DPM St. Luke's Hospital and Health Network
PRS Account St. Luke's Hospital and Health Network, Pennsylvania
Verification Date July 2012

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