Vitamin C Supplementation as a Preventive Treatment of Diabetic Peripheral Neuropathy

Diabetic Neuropathies Clinical Trial

Official title:

Vitamin C Supplementation as a Preventive Treatment of Diabetic Peripheral Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00634998
• Other study ID #: 10046-001
• Secondary ID: 06H-2958-9918
• Status: Completed
• Phase: Phase 1
• Start date: November 2007
• Est. completion date: August 2008

Study information

• Verified date: April 2023
• Source: Washington State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Peripheral Nervous System Diseases

Intervention

Dietary Supplement:
• Vitamin C
1000mg Vitamin C capsules orally twice daily
• Placebo
1000mg Placebo capsules orally twice daily for 90 days

Locations

Country	Name	City	State
United States	Washington State University, College of Pharmacy, Department of Pharmacotherapy	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Washington State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in intracellular erythrocyte sorbitol levels		Changes at 90 days compared to baseline
Primary	Changes in aldose reductase enzyme activity		Activity at 90 days compared to baseline
Primary	Changes in aldose reductase enzyme levels		Levels at 90 days compared to baseline
Secondary	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		Changes at 90 days compared to baseline