Clinical Trials Directory

Trials / Terminated

TerminatedNCT00004345

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

Status
Terminated
Phase
Study type
Observational
Enrollment
100 (planned)
Sponsor
National Center for Research Resources (NCRR) · NIH
Sex
All
Age
0 Years
Healthy volunteers
Accepted

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.

Conditions

Timeline

Start date
1999-10-01
First posted
1999-10-19
Last updated
2005-06-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00004345. Inclusion in this directory is not an endorsement.