- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004345
Study of Dietary N-3 Fatty Acids in Patients With Retinitis Pigmentosa and Usher Syndrome
OBJECTIVES: I. Examine the concentration of docosahexanoic acid (DHA) and other n-3 fatty acids in plasma, erythrocyte, and adipose tissue in patients with various forms of retinitis pigmentosa and Usher syndrome.
II. Determine the synthesis and catabolism of DHA from linolenic acid in these patients.
III. Determine the synthesis, absorption, and catabolism of DHA under different dietary conditions in these patients.
Study Overview
Status
Conditions
Detailed Description
PROTOCOL OUTLINE: Patients may participate in one or more of the arms of this study.
Arm I (adipose tissue study): Adipose tissue is collected from the buttocks of patients with Usher II retinitis pigmentosa (RP), patients with non-Usher RP, and control subjects. Dietary histories are obtained from all patients and subjects.
Arm II (isotope study): Patients meeting the same criteria as in arm I receive oral D5-labeled linolenic acid and oral D4-labeled linolenic acid that is dissolved in oil and incorporated into foods. Subjects must avoid eating fish and shellfish during the 35 days of the isotope study. Blood samples are collected at 0, 8, 24, and 48 hours, daily on days 3-7, and then on days 10, 18, and 35.
Arm III (flaxseed oil feeding): Patients with all types of RP and control subjects receive flaxseed oil, a form of linolenic acid, for 12 weeks. Subjects may also receive high oleic safflower oil or olive oil as a control fat for 12 weeks. Subjects complete a diet history at the end of each fatty acid supplementation period. All subjects must follow a diet free of seafood and fish oil supplements.
Study Type
Enrollment
Contacts and Locations
Study Locations
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Oregon
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Portland, Oregon, United States, 97201-3098
- Oregon Health Sciences University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
PROTOCOL ENTRY CRITERIA:
- Retinitis pigmentosa, including: Usher syndrome (types I and II) Simplex
- The following inheritance patterns eligible: X-linked recessive; Autosomal dominant; Autosomal recessive
Study Plan
How is the study designed?
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: William Connor, Oregon Health and Science University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Eye Diseases
- Neurologic Manifestations
- Disease
- Congenital Abnormalities
- Retinal Degeneration
- Retinal Diseases
- Genetic Diseases, Inborn
- Otorhinolaryngologic Diseases
- Ear Diseases
- Eye Diseases, Hereditary
- Retinal Dystrophies
- Sensation Disorders
- Abnormalities, Multiple
- Hearing Disorders
- Vision Disorders
- Deaf-Blind Disorders
- Hearing Loss, Sensorineural
- Blindness
- Hearing Loss
- Deafness
- Syndrome
- Retinitis
- Retinitis Pigmentosa
- Usher Syndromes
Other Study ID Numbers
- 199/11904
- OHSU-2650
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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