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Sponsored by: |
National Eye Institute (NEI) |
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Information provided by: | National Eye Institute (NEI) |
ClinicalTrials.gov Identifier: | NCT00346333 |
The purpose of this trial is to determine whether a nutritional supplement in addition to vitamin A will slow the course of retinitis pigmentosa.
Condition | Intervention | Phase |
---|---|---|
Retinitis Pigmentosa Inherited Retinal Degeneration |
Dietary Supplement: Nutritional supplement Dietary Supplement: Vitamin A palmitate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomized Clinical Trial for Retinitis Pigmentosa |
Enrollment: | 241 |
Study Start Date: | August 2003 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
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.
The 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 supplement 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 for the 30-2 program of the Humphrey Field analyzer (HFA). In addition, computer-averaged 30-Hz cone ERG amplitudes and visual acuity are measured annually.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Harvard Medical School ( Eliot L. Berson, M.D. ) |
Study ID Numbers: | NEI-126 |
Study First Received: | June 27, 2006 |
Last Updated: | December 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00346333 |
Health Authority: | United States: Food and Drug Administration |
Pigmentary retinopathy Retinol palmitate Genetic Diseases, Inborn Vitamin A Eye Diseases Cone rod dystrophy |
Retinitis Pigmentosa Retinitis Eye Diseases, Hereditary Retinal Degeneration Retinal Diseases Retinal degeneration |
Anticarcinogenic Agents Antioxidants Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Growth Substances |
Vitamins Physiological Effects of Drugs Micronutrients Protective Agents Pharmacologic Actions |