Vitamin E Treatment for Long-Chain 3-Hydroxyacyl Coenzyme A (CoA) Dehydrogenase (LCHAD) Associated Neuropathy
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|ClinicalTrials.gov Identifier: NCT00840112|
Recruitment Status : Terminated (New data does not support a role of vitamin E in LCHAD associated neuropathy.)
First Posted : February 10, 2009
Last Update Posted : October 21, 2015
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 or disease||Intervention/treatment||Phase|
|Peripheral Neuropathy Mitochondrial Trifunctional Protein Deficiency||Dietary Supplement: Vitamin E supplement||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Vitamin E Treatment for LCHAD Associated Neuropathy|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||October 2015|
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
- Plasma Vitamin E Concentrations [ Time Frame: 6 months ]
- Neurological examinations: Sensory exam, muscle weakness exam and deep tendon reflex exam [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00840112
|United States, Oregon|
|Oregon Health and Sciences University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Melanie Gillingham, Ph.D||Oregon Health and Science University|