Vitamin C Supplementation as a Preventive Treatment of Diabetic Peripheral Neuropathy

Study Overview
=================
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.

Official Title
-----------------
Vitamin C Supplementation as a Preventive Treatment of Diabetic Peripheral Neuropathy

Conditions
-----------------
Diabetic Neuropathies

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin C
* Dietary Supplement: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 2<br>1000mg Placebo capsules orally twice daily for 90 days | Dietary Supplement: Placebo<br>* 1000mg Placebo capsules orally twice daily for 90 days<br>|
| Experimental: 1<br>1000mg Vitamin C capsules orally twice daily for 90 days | Dietary Supplement: Vitamin C<br>* 1000mg Vitamin C capsules orally twice daily<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin C, Ascorbic Acid, Diabetic Neuropathies