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

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ClinicalTrials.gov Identifier: NCT00004827
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : March 25, 2015
Sponsor:
Information provided by:
FDA Office of Orphan Products Development

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.


Condition or disease Intervention/treatment Phase
Retinitis Pigmentosa Drug: docosahexaenoic acid Not Applicable

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


Study Type : Interventional  (Clinical Trial)
Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : March 1996
Study Completion Date : June 2002






Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004827


Sponsors and Collaborators
Retina Foundation of the Southwest
Investigators
Study Chair: Dennis R. Hoffman Retina Foundation of the Southwest

ClinicalTrials.gov Identifier: NCT00004827     History of Changes
Other Study ID Numbers: 199/13351
RFS-FDR001232
First Posted: February 25, 2000    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: May 1998

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

Additional relevant MeSH terms:
Retinitis
Retinitis Pigmentosa
Cone-Rod Dystrophies
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn