Study of Dietary N-3 Fatty Acids in Patients With Retinitis Pigmentosa and Usher Syndrome
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Purpose
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.
| Condition |
|---|
|
Usher Syndrome Retinitis Pigmentosa |
| Study Type: | Observational |
| Study Design: | Primary Purpose: Screening |
| Estimated Enrollment: | 100 |
| Study Start Date: | October 1999 |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| United States, Oregon | |
| Oregon Health Sciences University | |
| Portland, Oregon, United States, 97201-3098 | |
| Study Chair: | William Connor | Oregon Health and Science University |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00004345 History of Changes |
| Other Study ID Numbers: | 199/11904, OHSU-2650 |
| Study First Received: | October 18, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Center for Research Resources (NCRR):
|
Usher syndrome ophthalmologic disorders rare disease retinitis pigmentosa |
Additional relevant MeSH terms:
|
Retinitis Retinitis Pigmentosa Usher Syndromes Retinal Diseases Eye Diseases Eye Diseases, Hereditary Retinal Dystrophies Retinal Degeneration Genetic Diseases, Inborn Deaf-Blind Disorders Deafness Hearing Loss |
Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases Hearing Loss, Sensorineural Sensation Disorders Neurologic Manifestations Nervous System Diseases Blindness Vision Disorders Abnormalities, Multiple Congenital Abnormalities Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013