Who is sponsoring NCT00933998?

NCT00933998 is sponsored by Carolina Musculoskeletal Institute.

What condition does NCT00933998 study?

NCT00933998 studies Diabetic Peripheral Neuropathy.

What drugs are being tested in NCT00933998?

Interventions: Metanx® (Oral L-methylfolate, Methylcobalamin and Pyridoxal 5'-phosphate).

What is the status of NCT00933998?

NCT00933998 is currently COMPLETED.

Last reviewed 2014-01-28 · How we verify

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

NCT00933998 NA COMPLETED

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.

Details

Lead sponsor	Carolina Musculoskeletal Institute
Phase	NA
Status	COMPLETED
Enrolment	20
Start date	2006-06

Conditions

Diabetic Peripheral Neuropathy

Interventions

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

Primary outcomes

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