Randomized Trial for Retinitis Pigmentosa

Randomized Trial for Retinitis Pigmentosa

Sponsors

Lead Sponsor: National Eye Institute (NEI)

Source National Eye Institute (NEI)
Brief Summary

The purpose of this trial is to determine whether a nutritional supplement in addition to vitamin A will slow the course of retinitis pigmentosa.

Detailed Description

Retinitis pigmentosa (RP) is a group of inherited retinal degenerations with a worldwide prevalence of approximately 1 in 4,000. Patients typically report night blindness and difficulty with midperipheral visual field in adolescence. As the condition progresses, they lose far peripheral visual field. Most patients have reductions in central vision by age 50 to 80 years. Based on electroretinograms (ERGs), the course of the disease can be slowed on average among adults on 15,000 IU/day of vitamin A palmitate. While conducting the trial on the effects of vitamin A on RP, it became apparent that another substance in the diet could be affecting the course of the disease. This prompted the present randomized, controlled trial.

This study is a randomized, controlled, double-masked trial with a planned duration of 5 years. Patients with the common forms of RP are assigned to either a test or a control group. All receive 15,000 IU/day of vitamin A palmitate in addition to the capsules under study. Participants will not know the contents of the supplement or the group to which they have been assigned until the end of the trial. The main outcome measurement is the total point score on the Humphrey Field Analyzer (HFA). In addition, computer-averaged 30-Hz cone ERG amplitudes and visual acuity are measured annually.

Overall Status Completed
Start Date May 1996
Completion Date September 1997
Phase Phase 3
Study Type Interventional
Condition
Intervention

Intervention Type: Drug

Intervention Name: Vitamin A

Intervention Type: Drug

Intervention Name: Nutritional Supplement

Eligibility

Criteria:

Inclusion Criteria:

Eligible patients must:

- Be between the ages of 18 and 56

- Be able to see the entire face of someone sitting across the table from them without scanning

- Read newspaper-size print without special magnifying aids

- Walk unaided in daylight

- Have a normal fasting serum vitamin A and normal liver function profile

- Be in good general health

- Reside in the United States

Exclusion Criteria:

- Women who are pregnant or planning to become pregnant cannot be included because of the risk of birth defects that could occur while they are on a vitamin A supplement.

Gender: All

Minimum Age: 18 Years

Maximum Age: 56 Years

Overall Official
Last Name Role Affiliation
Eliot Berson, MD Study Chair Berman-Gund Laboratory for the Study of Retinal Degenerations, Harvard Medical School
Location
Facility: Berman-Gund Laboratory for the Study of Retinal Degenerations, Harvard Medical School, Massachusetts Eye and Ear Infirmary
Location Countries

United States

Verification Date

September 2009

Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double

Source: ClinicalTrials.gov