Vitamin C Supplementation as a Preventive Treatment of Diabetic Peripheral Neuropathy

April 25, 2023 updated by: Joshua Neumiller, Washington State University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Spokane, Washington, United States, 99210-1495
        • Washington State University, College of Pharmacy, Department of Pharmacotherapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
1000mg Placebo capsules orally twice daily for 90 days
Dietary supplement: Placebo
1000mg Placebo capsules orally twice daily for 90 days
Experimental: 1
1000mg Vitamin C capsules orally twice daily for 90 days
Dietary supplement: Vitamin C
1000mg Vitamin C capsules orally twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in intracellular erythrocyte sorbitol levels
Time Frame: Changes at 90 days compared to baseline
Changes at 90 days compared to baseline
Changes in aldose reductase enzyme activity
Time Frame: Activity at 90 days compared to baseline
Activity at 90 days compared to baseline
Changes in aldose reductase enzyme levels
Time Frame: Levels at 90 days compared to baseline
Levels at 90 days compared to baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Changes at 90 days compared to baseline
Changes at 90 days compared to baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington State University

Investigators

  • Principal Investigator: Joshua J Neumiller, PharmD, Washington State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

March 5, 2008

First Submitted That Met QC Criteria

March 5, 2008

First Posted (Estimate)

March 13, 2008

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 25, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10046-001
  • 06H-2958-9918

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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