Vitamin C Supplementation as a Preventive Treatment of Diabetic Peripheral Neuropathy
Information source: Washington State University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetic Neuropathies
Intervention: Vitamin C (Dietary Supplement); Placebo (Dietary Supplement)
Phase: Phase 1
Status: Completed
Sponsored by: Washington State University Official(s) and/or principal investigator(s): Joshua J Neumiller, PharmD, Principal Investigator, Affiliation: Washington State University
Summary
The purpose of this pilot study is to determine whether vitamin C supplementation is
beneficial in treating and/or preventing diabetic peripheral neuropathy in people with type
2 diabetes.
Clinical Details
Official title: Vitamin C Supplementation as a Preventive Treatment of Diabetic Peripheral Neuropathy
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Primary outcome: Changes in intracellular erythrocyte sorbitol levelsChanges in aldose reductase enzyme activity Changes in aldose reductase enzyme levels
Secondary outcome: Changes in Neuropathic Pain Scale (NPS) measurement and quantitative sensory testing in the lower extremities via touch discrimination with Semmes-Weinstein monofilaments and vibratory sensation testing
Detailed description:
Painful diabetic peripheral neuropathy (DPN), a condition characterized by pain affecting
the feet, legs and hands that is often characterized as burning or a "pins and needles"
sensation, is estimated to affect up to 66% of the U. S. diabetic population. This pilot
study will examine the effect of a daily dose of ascorbic acid, a known aldose reductase
inhibitor, versus placebo, and the effect that it can have on intracellular erythrocyte (red
blood cell) sorbitol levels, aldose reductase activity and aldose reductase enzyme levels
utilizing benchtop methods, and effects on clinical DPN-associated pain reporting and
changes in quantitative sensory testing in the lower extremities via touch discrimination
and vibratory sensory testing in patients with Type 2 Diabetes Mellitus (T2DM) over the
course of 90 days of treatment.
Eligibility
Minimum age: 50 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- type 2 diabetes mellitus
- diabetic peripheral neuropathy
- A1C of 6. 0-10. 0%
Exclusion Criteria:
- Terminal diagnosis
- Dementia
- Anemia
- Significant renal dysfunction
- History of B-12 deficiency
- Peripheral vascular disease
- Current smoker
- History of kidney stones
- Current ascorbic acid use
- Presence or foot infection and/or ulcer
Locations and Contacts
Washington State University, College of Pharmacy, Department of Pharmacotherapy, Spokane, Washington 99210-1495, United States
Additional Information
Starting date: November 2007
Last updated: September 6, 2012
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