Vitamin E Treatment for Long-Chain 3-Hydroxyacyl Coenzyme A (CoA) Dehydrogenase (LCHAD) Associated Neuropathy

• Register: ClinicalTrials.gov
• Last refreshed on: 2 November 2015
• Main ID: NCT00840112
• Date of registration: 09/02/2009
• Prospective Registration: Yes
• Primary sponsor: Oregon Health and Science University
• Public title: Vitamin E Treatment for Long-Chain 3-Hydroxyacyl Coenzyme A (CoA) Dehydrogenase (LCHAD) Associated Neuropathy
• Scientific title: Vitamin E Treatment for LCHAD Associated Neuropathy
• Date of first enrolment: July 2010
• Target sample size: 1
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00840112
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Melanie Gillingham, Ph.D
• Affiliation: Oregon Health and Science University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Confirmed diagnosis of TFP, or LCHAD deficiency and progressive peripheral neuropathy

- Subjects must be > 7 years of age, and be willing to take vitamin E supplements.

Exclusion Criteria:



Age minimum: 7 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Peripheral Neuropathy

Mitochondrial Trifunctional Protein Deficiency

Intervention(s)

Dietary Supplement: Vitamin E supplement

Primary Outcome(s)

Plasma Vitamin E Concentrations [Time Frame: 6 months]

Secondary Outcome(s)

Neurological examinations: Sensory exam, muscle weakness exam and deep tendon reflex exam [Time Frame: 6 months]

Secondary ID(s)

OHSU eirb# 4929

F32DK065400

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Oregon State University

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)