Official Title
Vitamin C Supplementation as a Preventive Treatment of Diabetic Peripheral Neuropathy
Phase
Phase 1Lead Sponsor
Washington State UniversityStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Diabetic NeuropathiesIntervention/Treatment
vitamin c ...Study Participants
10The 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.
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.
1000mg Vitamin C capsules orally twice daily
1000mg Placebo capsules orally twice daily for 90 days
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
