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

Primary Purpose

Retinitis Pigmentosa

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

docosahexaenoic acid

About this trial

This is an interventional treatment trial for Retinitis Pigmentosa focused on measuring ophthalmologic disorders, rare disease, retinitis pigmentosa

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00004827

First Posted

February 24, 2000

Last Updated

March 24, 2015

Sponsor

Retina Foundation of the Southwest

1. Study Identification

Unique Protocol Identification Number

NCT00004827

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 1998

Overall Recruitment Status

Completed

Study Start Date

March 1996 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Retina Foundation of the Southwest

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Retinitis Pigmentosa

Keywords

ophthalmologic disorders, rare disease, retinitis pigmentosa

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

46 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

docosahexaenoic acid

10. Eligibility

Sex

Male

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dennis R. Hoffman

Organizational Affiliation

Retina Foundation of the Southwest

Official's Role

Study Chair

12. IPD Sharing Statement

Citations:

PubMed Identifier

32573764

Citation

Schwartz SG, Wang X, Chavis P, Kuriyan AE, Abariga SA. Vitamin A and fish oils for preventing the progression of retinitis pigmentosa. Cochrane Database Syst Rev. 2020 Jun 18;6(6):CD008428. doi: 10.1002/14651858.CD008428.pub3.

Results Reference

derived

Learn more about this trial

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

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