Vitamin C Supplementation as a Preventive Treatment of Diabetic Peripheral Neuropathy
2 other identifiers
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Nov 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 5, 2008
CompletedFirst Posted
Study publicly available on registry
March 13, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedApril 27, 2023
April 1, 2023
9 months
March 5, 2008
April 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 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
Changes at 90 days compared to baseline
Study Arms (2)
2
PLACEBO COMPARATOR1000mg Placebo capsules orally twice daily for 90 days
1
EXPERIMENTAL1000mg Vitamin C capsules orally twice daily for 90 days
Interventions
Eligibility Criteria
You may qualify if:
- type 2 diabetes mellitus
- diabetic peripheral neuropathy
- A1C of 6.0-10.0%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington State University, College of Pharmacy, Department of Pharmacotherapy
Spokane, Washington, 99210-1495, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joshua J Neumiller, PharmD
Washington State University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 5, 2008
First Posted
March 13, 2008
Study Start
November 1, 2007
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
April 27, 2023
Record last verified: 2023-04