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

This study has been completed.
Information provided by:
FDA Office of Orphan Products Development Identifier:
First received: February 24, 2000
Last updated: March 24, 2015
Last verified: May 1998


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
Primary Purpose: Treatment

Resource links provided by NLM:

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

Estimated Enrollment: 46
Study Start Date: March 1996
Estimated Study Completion Date: June 2002
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.

Completion date provided represents the completion date of the grant per OOPD records


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


--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
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Please refer to this study by its identifier: NCT00004827

Sponsors and Collaborators
Retina Foundation of the Southwest
Study Chair: Dennis R. Hoffman Retina Foundation of the Southwest
  More Information Identifier: NCT00004827     History of Changes
Other Study ID Numbers: 199/13351
Study First Received: February 24, 2000
Last Updated: March 24, 2015

Keywords provided by FDA Office of Orphan Products Development:
ophthalmologic disorders
rare disease
retinitis pigmentosa

Additional relevant MeSH terms:
Retinitis Pigmentosa
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn processed this record on August 18, 2017