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

This study has been terminated.
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00004345
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: July 2002

October 18, 1999
June 23, 2005
October 1999
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Complete list of historical versions of study NCT00004345 on ClinicalTrials.gov Archive Site
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Study of Dietary N-3 Fatty Acids in Patients With Retinitis Pigmentosa and Usher Syndrome
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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.

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.

Observational
Primary Purpose: Screening
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  • Usher Syndrome
  • Retinitis Pigmentosa
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
100
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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
Both
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Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004345
199/11904, OHSU-2650
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National Center for Research Resources (NCRR)
Oregon Health and Science University
Study Chair: William Connor Oregon Health and Science University
National Center for Research Resources (NCRR)
July 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP