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

This study has been terminated.
(New data does not support a role of vitamin E in LCHAD associated neuropathy.)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Oregon State University
Information provided by:
Oregon Health and Science University Identifier:
First received: February 9, 2009
Last updated: October 20, 2015
Last verified: July 2010


People with a genetic defect in the ability to burn fat can also develop a problem with the nerves in their feet. The nerve problem, or neuropathy, can limit their ability to walk. Part of the treatment of their genetic defect in the ability to burn fat is to eat a very low fat diet. Vitamin E is found only in fatty foods like oils and nuts. People with a genetic defect in the ability to burn fat may have low vitamin E because of their low fat diet. The purpose of this study is to test whether vitamin E supplements can improve the nerve function in the feet of people with a genetic defect in the ability to burn fat.


Blood samples will be drawn at the beginning of the study, after 2 months and after 6 months of vitamin E supplements. The blood will be analyzed for plasma vitamin E concentrations. Around the time of each blood draw subjects will record all the food and beverages he or she consumes for three days. The subject will send the record to the investigator. Subjects will have a physical exam by a doctor specializing in nerves, a neurologist before and after taking vitamin E. They will have nerve function measured with a test called a nerve conduction velocity or NCV. Subjects will be given 800 international units (IU) of vitamin E per day for 6 months.

Condition Intervention
Peripheral Neuropathy
Mitochondrial Trifunctional Protein Deficiency
Dietary Supplement: Vitamin E supplement

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vitamin E Treatment for LCHAD Associated Neuropathy

Resource links provided by NLM:

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Plasma Vitamin E Concentrations [ Time Frame: 6 months ]

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

Enrollment: 1
Study Start Date: July 2010
Study Completion Date: October 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LCHAD/TFP with peripheral neuropathy
Subjects diagnosed with LCHAD or TFP and with documented peripheral neuropathy
Dietary Supplement: Vitamin E supplement
400 IU (268 mg) capsules of will be provided for the subjects. Subjects will be instructed to take one capsule with meals 2 times per day.
Other Name: alpha tocopherol

  Show Detailed Description


Ages Eligible for Study:   7 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00840112

United States, Oregon
Oregon Health and Sciences University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Oregon State University
Principal Investigator: Melanie Gillingham, Ph.D Oregon Health and Science University
  More Information

Responsible Party: Melanie Gillingham, Ph.D., Oregon Health and Sciences University Identifier: NCT00840112     History of Changes
Other Study ID Numbers: OHSU eirb# 4929
F32DK065400 ( US NIH Grant/Contract Award Number )
Study First Received: February 9, 2009
Last Updated: October 20, 2015

Keywords provided by Oregon Health and Science University:
Long-chain 3-hydroxyacyl CoA dehydrogenase (LCHAD)
Mitochondrial trifunctional protein (TFP)
LCHAD/TFP deficiency with peripheral neuropathy

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Lipid Metabolism, Inborn Errors
Mitochondrial Myopathies
Protein Deficiency
Neuromuscular Diseases
Nervous System Diseases
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Lipid Metabolism Disorders
Metabolic Diseases
Heart Diseases
Cardiovascular Diseases
Muscular Diseases
Musculoskeletal Diseases
Mitochondrial Diseases
Deficiency Diseases
Nutrition Disorders
Vitamin E
Growth Substances
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017