Restoration of Cutaneous Sensorum in Patients With Diabetic Peripheral Neuropathy (DPN) Via Metanx®

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00933998

Enrollment

Registered

2009-07-08

Start date

2006-06-30

Completion date

Unknown

Last updated

2014-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Peripheral Neuropathy

Keywords

DPN

Brief 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. 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.

Interventions

OTHERMetanx® (Oral L-methylfolate, Methylcobalamin and Pyridoxal 5'-phosphate)

One pill twice a day for 2 weeks. Then one pill a day until 12 month study is up.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

Inclusion criteria

* 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 * 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

Exclusion criteria

* History of back problems (Surgery or ECSI) or other large fiber neuropathies * History of chemotherapy * History of chemical exposure

Design outcomes

Primary

Measure	Time frame	Description
Epidermal Nerve Density Count	2 years	Measure increase or decrease in ENFD count after 12 months of Metanx therapy in patients with diabetic peripheral neuropathy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026