Diabetic NeuropathiesPhase 1NCT00634998
Vitamin C Supplementation as a Preventive Treatment of Diabetic Peripheral Neuropathy
A Phase 1 study testing Vitamin C in people with Diabetic Neuropathies, run by Washington State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Diabetic Neuropathies
- What is being tested?
- Vitamin C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Aug 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes mellitus
- diabetic peripheral neuropathy
- A1C of 6.0-10.0%
Who cannot join
- Terminal diagnosis
- Dementia
- Anemia
- Significant renal dysfunction
- History of B-12 deficiency
- Peripheral vascular disease
Show all 10Show fewer
- Current smoker
- History of kidney stones
- Current ascorbic acid use
- Presence or foot infection and/or ulcer
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington State University, College of Pharmacy, Department of Pharmacotherapy
Spokane, Washington, 99210-1495
About this study
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.
Read the 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.
- Conditions
- Diabetic Neuropathies
- Being tested
- Vitamin C, Placebo
- Keywords
- Vitamin C, Ascorbic Acid, Diabetic Neuropathies
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDietary supplement
1000mg Vitamin C capsules orally twice daily
PlaceboDietary supplement
1000mg Placebo capsules orally twice daily for 90 days
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | 1000mg Placebo capsules orally twice daily for 90 days Receives: Dietary Supplement: Placebo |
| 1 | Experimental | 1000mg Vitamin C capsules orally twice daily for 90 days Receives: Dietary Supplement: Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in intracellular erythrocyte sorbitol levels
Measured: Changes at 90 days compared to baseline
Changes in aldose reductase enzyme activity
Measured: Activity at 90 days compared to baseline
Changes in aldose reductase enzyme levels
Measured: 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
Measured: Changes at 90 days compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startNov 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Neumiller, Washington State University
- Investigators
- Joshua J Neumiller, PharmD, Principal investigator, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00634998
- Sponsor's protocol ID
- 10046-001
- Other IDs
- 06H-2958-9918
- Status last verified
- Apr 2023
- First submitted
- 5 Mar 2008
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin C Supplementation as a Preventive Treatment of Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT00634998
- Acronym / sponsor ID
- 10046-001
- Conditions
- Diabetic Neuropathies
- Keywords
- Vitamin C, Ascorbic Acid, Diabetic Neuropathies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 13 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Dietary Supplement: Placebo1000mg Placebo capsules orally twice daily for 90 days |
| 1 | Experimental | Dietary Supplement: Vitamin C1000mg Vitamin C capsules orally twice daily for 90 days |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- type 2 diabetes mellitus
- diabetic peripheral neuropathy
- A1C of 6.0-10.0%
Key exclusion criteria (10 listed)
- Terminal diagnosis
- Dementia
- Anemia
- Significant renal dysfunction
- History of B-12 deficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin C1000mg Vitamin C capsules orally twice daily | Dietary supplement | 1 |
| Placebo1000mg Placebo capsules orally twice daily for 90 days | Dietary supplement | 2 |
Primary outcome
Changes in intracellular erythrocyte sorbitol levels
Time frame: Changes at 90 days compared to baseline
Changes in aldose reductase enzyme activity
Time frame: Activity at 90 days compared to baseline
Changes in aldose reductase enzyme levels
Time frame: Levels at 90 days compared to baseline
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua J Neumiller, PharmD principal investigator
Washington State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vitamin C in people with Diabetic Neuropathies, run by Washington State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in intracellular erythrocyte sorbitol levels (time frame: Changes at 90 days compared to baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.