NCT00933998

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Carolina Musculoskeletal Institute · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Diabetic Peripheral Neuropathy

Interventions

Type	Name	Description
OTHER	Metanx® (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.

Timeline

• Start date: 2006-06-01
• Primary completion: 2008-10-01
• First posted: 2009-07-08
• Last updated: 2014-01-29

Locations

1 site across 1 country: United States