Randomized Trial of Vitamin A and Vitamin E Supplementation for Retinitis Pigmentosa
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00000114|
Recruitment Status : Completed
First Posted : September 24, 1999
Last Update Posted : September 17, 2009
|Condition or disease||Intervention/treatment||Phase|
|Retinitis Pigmentosa||Drug: Vitamin E Drug: Vitamin A||Phase 3|
Retinitis pigmentosa (RP) is a group of inherited retinal degenerations with a worldwide prevalence of about 1 in 4,000. Patients typically report night blindness in adolescence and lose vision in the midperipheral followed by far-peripheral visual field in adulthood due to progressive loss of both rod and cone function. Most patients have reductions in central vision by age 50 to 80 years. Modern-day electroretinograms (ERGs) make it possible to record retinal responses from most patients with remaining vision and thereby monitor objectively the course of their disease.
While the natural course of retinal degeneration in the common forms of RP was being studied, it was noted that a subgroup of patients aged 18 through 49 who were treating themselves with both vitamin A and vitamin E and other nutritional supplements exhibited less decline in ERG amplitude over a 2-year period. These preliminary findings, as well as the known roles of vitamins A and E in maintaining normal photoreceptor function and structure, prompted this randomized, controlled trial to determine whether these vitamins alone or in combination would halt or slow the progression of the common forms of RP.
This study was a randomized, controlled double-masked trial with 2 x 2 factorial design and duration of 4 to 6 years. Patients were assigned to one of four treatment groups:
15,000 IU/day vitamin A
15,000 IU/day vitamin A + 400 IU/day vitamin E
trace amounts of both vitamins A and E
400 IU/day of vitamin E
The main outcome measure was the 30-Hz cone ERG amplitude. In addition, visual field and visual acuity were measured annually.
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Factorial Assignment|
|Study Start Date :||May 1984|
|Actual Study Completion Date :||June 1987|