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Completed

NCT Number: NCT00634998

Vitamin C Supplementation as a Preventive Treatment of Diabetic Peripheral Neuropathy

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.

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Key information

Conditions

Diabetic Neuropathies Diabetes Complications Diabetes Mellitus Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Washington State University, College of Pharmacy, Department of Pharmacotherapy

Spokane, Washington, 99210-1495, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin C

Dietary Supplement

1000mg Vitamin C capsules orally twice daily

Placebo

Dietary Supplement

1000mg Placebo capsules orally twice daily for 90 days

Primary outcomes

  1. Changes in intracellular erythrocyte sorbitol levels

    Time frame: Changes at 90 days compared to baseline

  2. Changes in aldose reductase enzyme activity

    Time frame: Activity at 90 days compared to baseline

  3. Changes in aldose reductase enzyme levels

    Time frame: Levels at 90 days compared to baseline

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Washington State University

Other

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 13, 2008
Registry last updated
Apr 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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