Randomized Trial for Retinitis Pigmentosa
The purpose of this trial is to determine whether a nutritional supplement in addition to vitamin A will slow the course of retinitis pigmentosa.
Drug: Vitamin A
Drug: Nutritional Supplement
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Randomized Trial for Retinitis Pigmentosa|
|Study Start Date:||May 1996|
|Estimated Study Completion Date:||September 1997|
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.
|United States, Massachusetts|
|Berman-Gund Laboratory for the Study of Retinal Degenerations, Harvard Medical School, Massachusetts Eye and Ear Infirmary|
|Boston, Massachusetts, United States, 02114|
|Study Chair:||Eliot Berson, MD||Berman-Gund Laboratory for the Study of Retinal Degenerations, Harvard Medical School|