DHA and X-Linked Retinitis Pigmentosa

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00100230
• Date of registration: 27/12/2004
• Prospective Registration: No
• Primary sponsor: Retina Foundation of the Southwest
• Public title: DHA and X-Linked Retinitis Pigmentosa
• Scientific title: Investigation of Effectiveness and Safety of High Dose Docosahexaenoic Acid (DHA) in X-Linked Retinitis Pigmentosa
• Date of first enrolment: September 2004
• Target sample size: 78
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00100230
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Dennis R. Hoffman, Ph.D.
• Affiliation: Retina Foundation of the Southwest

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of RP by a retinal specialist

- Clinical diagnosis consistent with X-linked inheritance

- Enrolling minors and young adults (early onset of X-linked disease; ages 7 to 32)

- Measurable cone ERG responses --patients with less than 0.64 microvolt response to
31-Hz flicker will be excluded as they are more likely to become undetectable during
the study

- Both eyes must meet entry criteria as both will be tested (i.e., no cataracts
requiring surgery or retinal detachments).

- Media clarity sufficient for fundus photography

- Able to return to study site at yearly intervals

- Willing to supply blood samples at 6-month intervals

- Judiciously take the placebo or DHA supplement for the 4-year study duration

- Patient/parent/guardian understands and signs consent form.

Exclusion Criteria:

- Excessive fish consumption (e.g., cold water fish such as salmon, tuna, sardines)
and/or fish oil supplementation (or other oil containing DHA)

- Baseline RBC-DHA levels showing evidence of supplementation (a typical level of
RBC-DHA in normals is about 3.8%)

- Chronic metabolic disease that may interfere with fatty acid metabolism or require
anti-coagulant medication

No ethnic or racial groups will be excluded.



Age minimum: 7 Years
Age maximum: 32 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Retinitis Pigmentosa

X-linked Genetic Diseases

Intervention(s)

Drug: docosahexaenoic acid OR corn/soy oil placebo

Primary Outcome(s)

Rate of LOSS of 31 Hertz Cone Electroretinographic Function [Time Frame: 4 years]

Secondary Outcome(s)

Rate of LOSS of Rod Electroretinographic Function [Time Frame: 4 years]

Secondary ID(s)

FD-R-002543

2543

5R01FD002543

C-TX02-0704-0274

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Foundation Fighting Blindness

DSM Nutritional Products, Inc.

Results

• Results available: Yes
• Date Posted: 17/03/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00100230