Study of Docosahexaenoic Acid (DHA) Supplementation in Patients With X-Linked Retinitis Pigmentosa - Tabular View

Tracking Information

First Received Date ^ICMJE

February 24, 2000

Last Updated Date

May 15, 2009

Start Date ^ICMJE

March 1996

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004827 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Study of Docosahexaenoic Acid (DHA) Supplementation in Patients With X-Linked Retinitis Pigmentosa

Official Title ^ICMJE

Brief Summary

OBJECTIVES:

I. Evaluate the potential of nutritional docosahexaenoic acid (DHA) supplementation to normalize the level of DHA in red blood cells, and to retard the progression of visual function loss in patients with early stage X-linked retinitis pigmentosa.

Detailed Description

PROTOCOL OUTLINE: This is a randomized, parallel, double blind study. Patients receive 2 gel capsules per day of either docosahexaenoic acid (DHA) enriched oil or a placebo oil. Oral DHA supplementation continues daily for 3 years.

All patients are followed every 6 months for the 3 year duration of the study.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Parallel Assignment

Condition ^ICMJE

Retinitis Pigmentosa

Intervention ^ICMJE

Drug: docosahexaenoic acid

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of X-linked retinitis pigmentosa

Early stage disease Sufficient cone function determined by recordable ERG (30 Hz amplitude; greater than 0.32 microvolts) Visual fields greater than 20 degrees Sufficient rod function (greater than 3.0 microvolts amplitude)

Media clarity sufficient for fundus photography

--Prior/Concurrent Therapy--

No concurrent use of anticoagulant medication

--Patient Characteristics--

No chronic metabolic disease that may interfere with fatty acid metabolism
No bleeding of clinical significance

Gender

Male

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00004827

Responsible Party

Study ID Numbers ^ICMJE

199/13351, RFS-FDR001232

Study Sponsor ^ICMJE

FDA Office of Orphan Products Development

Collaborators ^ICMJE

Retina Foundation of the Southwest

Investigators ^ICMJE

Study Chair:

Dennis R. Hoffman

Retina Foundation of the Southwest

Information Provided By

FDA Office of Orphan Products Development

Verification Date

May 1998

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