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

Primary Purpose

Usher Syndrome, Retinitis Pigmentosa

Status

Terminated

Phase

Locations

United States

Study Type

Observational

Intervention

About this trial

This is an observational trial for Usher Syndrome focused on measuring Usher syndrome, ophthalmologic disorders, rare disease, retinitis pigmentosa

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Oregon Health Sciences University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00004345

First Posted

October 18, 1999

Last Updated

June 23, 2005

Sponsor

National Center for Research Resources (NCRR)

Collaborators

Oregon Health and Science University

1. Study Identification

Unique Protocol Identification Number

NCT00004345

Brief Title

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

Study Type

Observational

2. Study Status

Record Verification Date

July 2002

Overall Recruitment Status

Terminated

Study Start Date

October 1999 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

National Center for Research Resources (NCRR)

Collaborators

Oregon Health and Science University

4. Oversight

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Usher Syndrome, Retinitis Pigmentosa

Keywords

Usher syndrome, ophthalmologic disorders, rare disease, retinitis pigmentosa

7. Study Design

Enrollment

100 (false)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

0 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William Connor

Organizational Affiliation

Oregon Health and Science University

Official's Role

Study Chair

Facility Information:

Facility Name

Oregon Health Sciences University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97201-3098

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

32573764

Citation

Schwartz SG, Wang X, Chavis P, Kuriyan AE, Abariga SA. Vitamin A and fish oils for preventing the progression of retinitis pigmentosa. Cochrane Database Syst Rev. 2020 Jun 18;6(6):CD008428. doi: 10.1002/14651858.CD008428.pub3.

Results Reference

derived

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

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