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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 levels

Changes 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

Page last updated: August 20, 2015

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