Home | All trials

[RDF data]
Trial NCT00000116

Resource URI: http://static.linkedct.org/resource/trials/NCT00000116
linkedct:brief_title Randomized Trial for Retinitis Pigmentosa
linkedct:condition <http://static.linkedct.org/resource/condition/11573>
linkedct: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.
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_maximum_age 56 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date September 1997
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date September 23, 1999
linkedct:id NCT00000116
rdfs:label Trial NCT00000116
linkedct:lastchanged_date September 16, 2009
linkedct:lead_sponsor_agency National Eye Institute (NEI)
linkedct:location <http://static.linkedct.org/resource/location/147380>
linkedct:nct_id NCT00000116
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Randomized Trial for Retinitis Pigmentosa
linkedct:org_study_id NEI-12
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/15941>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000116>
linkedct:phase Phase 3
linkedct:results_reference <http://static.linkedct.org/resource/results_reference/4099>
linkedct:results_reference <http://static.linkedct.org/resource/results_reference/4100>
linkedct:source National Eye Institute (NEI)
linkedct:start_date May 1996
linkedct:study_design Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date September 2009