Vitamin C Supplementation as a Preventive Treatment of Diabetic Peripheral Neuropathy

Washington State University

Status and phase: Completed; Phase 1

Conditions: Diabetic Neuropathies

Treatments: Dietary Supplement: Vitamin C; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00634998

10046-001

06H-2958-9918

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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10 participants in 2 patient groups, including a placebo group

2

Placebo Comparator group

Description:

1000mg Placebo capsules orally twice daily for 90 days

Treatment:

Dietary Supplement: Placebo

1

Experimental group

Description:

1000mg Vitamin C capsules orally twice daily for 90 days

Treatment:

Dietary Supplement: Vitamin C