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

This study has been completed.

First Received on February 24, 2000. Last Updated on May 15, 2009 History of Changes

Sponsor:	FDA Office of Orphan Products Development
Collaborator:	Retina Foundation of the Southwest
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00004827

Purpose

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.

Condition	Intervention
Retinitis Pigmentosa	Drug: docosahexaenoic acid

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: Lenz microphthalmia syndrome oculofaciocardiodental syndrome Peters plus syndrome retinitis pigmentosa X-linked juvenile retinoschisis Help Me Understand Genetics

Drug Information available for: Docosahexaenoic acids Eicosapentaenoic acid

U.S. FDA Resources

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:	46
Study Start Date:	March 1996

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.

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004827

Sponsors and Collaborators

FDA Office of Orphan Products Development

Retina Foundation of the Southwest

Investigators

Study Chair:

Dennis R. Hoffman

Retina Foundation of the Southwest

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00004827 History of Changes
Other Study ID Numbers:	199/13351, RFS-FDR001232
Study First Received:	February 24, 2000
Last Updated:	May 15, 2009
Health Authority:	United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:

ophthalmologic disorders
rare disease
retinitis pigmentosa

Additional relevant MeSH terms:

Retinitis
Retinitis Pigmentosa
Retinal Diseases
Eye Diseases

Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on February 09, 2012