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NCT00004827 Clinical Trial

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

Retinitis Pigmentosa Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00004827
Other study ID # 199/13351
Secondary ID RFS-FDR001232
Status Completed
Phase N/A
First received February 24, 2000
Last updated March 24, 2015
Start date March 1996
Est. completion date June 2002

Study information
Verified date May 1998
Source FDA Office of Orphan Products Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 46
Est. completion date June 2002
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• docosahexaenoic acid

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Retina Foundation of the Southwest
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