Metanx Effects on Nerve Fiber Density in Neuropathic Diabetics (SLHN2011-18)
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| ClinicalTrials.gov Identifier: NCT01503892 |
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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
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Sponsor:
St. Luke's Hospital and Health Network, Pennsylvania
Collaborators:
Goldfarb Foundation
Pamlab, L.L.C.
Information provided by (Responsible Party):
Edwin S. Hart III, St. Luke's Hospital and Health Network, Pennsylvania
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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.
| 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 |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Metanx Effects on Nerve Fiber Density in Neuropathic Diabetics |
| Study Start Date : | December 2011 |
| Estimated Primary Completion Date : | October 2013 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Small fiber neuropathy
Drug Information available for:
Mecobalamin
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
The control group will receive placebo pill twice daily for twelve months.
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Drug: Placebo
Placebo- one tablet twice daily for twelve months. |
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Active Comparator: Metanx
Metanx group will receive one pill twice daily for twelve months.
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Dietary Supplement: Metanx
Metanx- one tablet twice daily for twelve months |
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- Subjective improvement [ Time Frame: 1 year ]Improvement in the subjective score versus the placebo group.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Type 2 Diabetics
- Pre-diabetics
- Symptoms of peripheral neuropathy
Exclusion Criteria:
- Pregnancy
- Under age 18
- HIV (+)
Information from the National Library of Medicine
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
Contacts
| Contact: Edwin S. Hart III, DPM | 610-868-4300 | ehart@footmed.com |
Locations
| 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 ehart@footmed.com | |
Sponsors and Collaborators
St. Luke's Hospital and Health Network, Pennsylvania
Goldfarb Foundation
Pamlab, L.L.C.
Investigators
| Principal Investigator: | Edwin S. Hart III, DPM | St. Luke's Hospital and Health Network |
Additional Information:
| Responsible Party: | Edwin S. Hart III, Principal Investigator, St. Luke's Hospital and Health Network, Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT01503892 History of Changes |
| Other Study ID Numbers: |
StLukeHHN |
| First Posted: | January 4, 2012 Key Record Dates |
| Last Update Posted: | July 17, 2012 |
| Last Verified: | July 2012 |
Keywords provided by Edwin S. Hart III, St. Luke's Hospital and Health Network, Pennsylvania:
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Small Fiber Neuropathy Metanx Effect on Small Fiber Neuropathy Metanx Effect on Diabetic Peripheral Neuropathy |
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Vitamin B 12 Vitamin B Complex |
Vitamins Micronutrients Growth Substances Physiological Effects of Drugs |