Vitamin C Supplementation as a Preventive Treatment of Diabetic Peripheral Neuropathy

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00634998

Enrollment

Registered

2008-03-13

Start date

2007-11-30

Completion date

2008-08-31

Last updated

2023-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Neuropathies

Keywords

Vitamin C, Ascorbic Acid, Diabetic Neuropathies

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.

Interventions

DIETARY_SUPPLEMENTVitamin C

1000mg Vitamin C capsules orally twice daily

DIETARY_SUPPLEMENTPlacebo

1000mg Placebo capsules orally twice daily for 90 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

50 Years to 70 Years

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

Design outcomes

Primary

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

Secondary

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	Changes at 90 days compared to baseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026