Vitamin C Supplementation as a Preventive Treatment of Diabetic Peripheral Neuropathy

NCT ID: NCT00634998

Last Updated: 2023-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-08-31

Brief Summary

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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

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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.

Conditions

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Diabetic Neuropathies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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2

1000mg Placebo capsules orally twice daily for 90 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

1000mg Placebo capsules orally twice daily for 90 days

1

1000mg Vitamin C capsules orally twice daily for 90 days

Group Type EXPERIMENTAL

Vitamin C

Intervention Type DIETARY_SUPPLEMENT

1000mg Vitamin C capsules orally twice daily

Interventions

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Vitamin C

1000mg Vitamin C capsules orally twice daily

Intervention Type DIETARY_SUPPLEMENT

Placebo

1000mg Placebo capsules orally twice daily for 90 days

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington State University

OTHER

Sponsor Role lead

Responsible Party

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Joshua Neumiller

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joshua J Neumiller, PharmD

Role: PRINCIPAL_INVESTIGATOR

Washington State University

Locations

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Washington State University, College of Pharmacy, Department of Pharmacotherapy

Spokane, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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06H-2958-9918

Identifier Type: -

Identifier Source: secondary_id

10046-001

Identifier Type: -

Identifier Source: org_study_id

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