Study of Dietary N-3 Fatty Acids in Patients With Retinitis Pigmentosa and Usher Syndrome - Full Text View

Sponsor:	National Center for Research Resources (NCRR)
Collaborator:	Oregon Health and Science University
Information provided by:	National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:	NCT00004345

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:	Screening

Resource links provided by NLM:

Genetics Home Reference related topics: Lenz microphthalmia syndrome nonsyndromic deafness oculofaciocardiodental syndrome Peters plus syndrome Usher syndrome X-linked juvenile retinoschisis

MedlinePlus related topics: Diets Usher Syndrome

U.S. FDA Resources

Further study details as provided by National Center for Research Resources (NCRR):

Estimated Enrollment:	100
Study Start Date:	October 1999

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004345

Locations

United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97201-3098

Sponsors and Collaborators

National Center for Research Resources (NCRR)

Oregon Health and Science University

Investigators

Study Chair:

William Connor

Oregon Health and Science University

More Information

No publications provided

Study ID Numbers:	199/11904, OHSU-2650
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004345 History of Changes
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:

Sensation Disorders
Vision Disorders
Retinitis
Deaf-Blind Disorders
Hearing Loss, Sensorineural
Usher Syndromes
Ear Diseases
Signs and Symptoms
Deafness
Hearing Disorders
Pathologic Processes
Syndrome
Retinitis Pigmentosa

Abnormalities, Multiple
Eye Diseases, Hereditary
Hearing Loss
Congenital Abnormalities
Retinal Diseases
Disease
Otorhinolaryngologic Diseases
Eye Diseases
Nervous System Diseases
Retinal Degeneration
Blindness
Genetic Diseases, Inborn
Neurologic Manifestations

ClinicalTrials.gov processed this record on November 05, 2009