Back to results

Vitamin C Supplementation as a Preventive Treatment of Diabetic Peripheral Neuropathy

Primary Purpose

Diabetic Neuropathies

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Vitamin C

Placebo

About this trial

This is an interventional prevention trial for Diabetic Neuropathies focused on measuring Vitamin C, Ascorbic Acid, Diabetic Neuropathies

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Washington State University, College of Pharmacy, Department of Pharmacotherapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Arm Description

1000mg Placebo capsules orally twice daily for 90 days

1000mg Vitamin C capsules orally twice daily for 90 days

Outcomes

Primary Outcome Measures

Changes in intracellular erythrocyte sorbitol levels

Changes in aldose reductase enzyme activity

Changes in aldose reductase enzyme levels

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00634998

First Posted

March 5, 2008

Last Updated

April 25, 2023

Sponsor

Washington State University

1. Study Identification

Unique Protocol Identification Number

NCT00634998

Brief Title

Vitamin C Supplementation as a Preventive Treatment of Diabetic Peripheral Neuropathy

Official Title

Vitamin C Supplementation as a Preventive Treatment of Diabetic Peripheral Neuropathy

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Washington State University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Neuropathies

Keywords

Vitamin C, Ascorbic Acid, Diabetic Neuropathies

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Description

1000mg Placebo capsules orally twice daily for 90 days

Arm Title

Arm Type

Experimental

Arm Description

1000mg Vitamin C capsules orally twice daily for 90 days

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin C

Intervention Description

1000mg Vitamin C capsules orally twice daily

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

1000mg Placebo capsules orally twice daily for 90 days

Primary Outcome Measure Information:

Title

Changes in intracellular erythrocyte sorbitol levels

Time Frame

Changes at 90 days compared to baseline

Title

Changes in aldose reductase enzyme activity

Time Frame

Activity at 90 days compared to baseline

Title

Changes in aldose reductase enzyme levels

Time Frame

Levels at 90 days compared to baseline

Secondary Outcome Measure Information:

Title

Time Frame

Changes at 90 days compared to baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joshua J Neumiller, PharmD

Organizational Affiliation

Washington State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Washington State University, College of Pharmacy, Department of Pharmacotherapy

City

Spokane

State/Province

Washington

ZIP/Postal Code

99210-1495

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Vitamin C Supplementation as a Preventive Treatment of Diabetic Peripheral Neuropathy

We'll reach out to this number within 24 hrs