Diabetic Peripheral NeuropathyNCT00933998
Restoration of Cutaneous Sensorum in Patients With Diabetic Peripheral Neuropathy (DPN) Via Metanx®
A study testing Metanx® (Oral L-methylfolate, Methylcobalamin and Pyridoxal 5'-phosphate) in people with Diabetic Peripheral Neuropathy, run by Carolina Musculoskeletal Institute at 1 site in United States.
Trial summary
The purpose of this research study is to determine if Metanx improves sensory neuropathy in persons with Type 2 diabetes. Metanx is a medical food available with a prescription from a physician. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- Metanx® (Oral L-methylfolate, Methylcobalamin and Pyridoxal 5'-phosphate)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Oct 2008
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Consecutive diabetic patients entering the office (private practice)
- Subjective symptoms of numbness, burning, paresthesia, etc.
- Failed Monofilament of at least two points on each foot
- Abnormal PSSD study
- Willing to participate in protocols or study
- Taking one Metanx tablet bid for 2 weeks then one Metanx tablet daily
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- Keep scheduled appointments for follow up studies
- Report any other medical interventions, studies, or medication changes
- Report any problems of medical or psycho-social matters to investigators
- HgbA1c NOT monitored or specific value required for participation
Who cannot join
- History of back problems (Surgery or ECSI) or other large fiber neuropathies
- History of chemotherapy
- History of chemical exposure
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolina Musculoskeletal Institute
Aiken, South Carolina, 29841
About this study
The purpose of this research study is to determine if Metanx improves sensory neuropathy in persons with Type 2 diabetes. Metanx is a medical food available with a prescription from a physician. It consists of L-methylfolate, Pyridoxal 5'-phosphate, and Methylcobalamin, which are the active forms of folate, vitamin B6, and vitamin B12, respectively. Subjects will be assigned to receive Metanx for 12 months. Baseline quantitative sensory testing will be done before the patient receives Metanx. Additional quantitative sensory testing will be done at 6 and 12 months to evaluate.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- Metanx® (Oral L-methylfolate, Methylcobalamin and Pyridoxal 5'-phosphate)
- Keywords
- DPN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metanx® (Oral L-methylfolate, Methylcobalamin and Pyridoxal 5'-phosphate)Other
Also called Metanx
One pill twice a day for 2 weeks. Then one pill a day until 12 month study is up.
| Study group | Role | What they receive |
|---|---|---|
| Metanx | Experimental | Metanx bid for 2 weeks then daily. Compare to non treated patient population Receives: Other: Metanx® (Oral L-methylfolate, Methylcobalamin and Pyridoxal 5'-phosphate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidermal Nerve Density Count
Measure increase or decrease in ENFD count after 12 months of Metanx therapy in patients with diabetic peripheral neuropathy
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startJun 2006
- Primary completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carolina Musculoskeletal Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Pamlab, L.L.C., Baylor University
- Responsible party
- Principal investigator, Mackie J. Walker, Jr., DPM, Carolina Musculoskeletal Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00933998
- Sponsor's protocol ID
- CMI-01
- Status last verified
- Jan 2014
- First submitted
- 7 Jul 2009
- Last updated
- 29 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoration of Cutaneous Sensorum in Patients With Diabetic Peripheral Neuropathy (DPN) Via Metanx®
- ClinicalTrials.gov ID
- NCT00933998
- Acronym / sponsor ID
- CMI-01
- Conditions
- Diabetic Peripheral Neuropathy
- Keywords
- DPN
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Carolina Musculoskeletal InstituteUniversity, hospital or other
- Collaborators
- Pamlab, L.L.C., Baylor University
- Study start
- Jun 2006
- Primary completion
- Oct 2008 (actual)
- First posted
- 8 Jul 2009 (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 research study is to determine if Metanx improves sensory neuropathy in persons with Type 2 diabetes. Metanx is a medical food available with a prescription from a physician. It consists of L-methylfolate, Pyridoxal 5'-phosphate, and Methylcobalamin, which are the active forms of folate, vitamin B6, and vitamin B12, respectively. Subjects will be assigned to receive Metanx for 12 months. Baseline quantitative sensory testing will be done before the patient receives Metanx. Additional quantitative sensory testing will be done at 6 and 12 months to evaluate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metanx | Experimental | Other: Metanx® (Oral L-methylfolate, Methylcobalamin and Pyridoxal 5'-phosphate)Metanx bid for 2 weeks then daily. Compare to non treated patient population |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Consecutive diabetic patients entering the office (private practice)
- Subjective symptoms of numbness, burning, paresthesia, etc.
- Failed Monofilament of at least two points on each foot
- Abnormal PSSD study
- Willing to participate in protocols or study
Key exclusion criteria (3 listed)
- History of back problems (Surgery or ECSI) or other large fiber neuropathies
- History of chemotherapy
- History of chemical exposure
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 |
|---|---|---|
| Metanx® (Oral L-methylfolate, Methylcobalamin and Pyridoxal 5'-phosphate)Also: MetanxOne pill twice a day for 2 weeks. Then one pill a day until 12 month study is up. | Other | Metanx |
Primary outcome
Epidermal Nerve Density Count
Time frame: 2 years
Measure increase or decrease in ENFD count after 12 months of Metanx therapy in patients with diabetic peripheral neuropathy
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 29 Jan 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metanx® (Oral L-methylfolate, Methylcobalamin and Pyridoxal 5'-phosphate) in people with Diabetic Peripheral Neuropathy, run by Carolina Musculoskeletal Institute 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 10 inclusion and 3 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 29 Jan 2014. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Epidermal Nerve Density Count (time frame: 2 years). 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 29 Jan 2014.