Effects of Lutein in Retinitis Pigmentosa
Primary Purpose
Retinitis Pigmentosa
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lutein (10 or 30 mg/day) capsules
Sponsored by
About this trial
This is an interventional treatment trial for Retinitis Pigmentosa
Eligibility Criteria
Sites / Locations
- Johns Hopkins Wilmer Eye Institute, Lions Vision Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00029289
First Posted
January 9, 2002
Last Updated
August 16, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00029289
Brief Title
Effects of Lutein in Retinitis Pigmentosa
Official Title
Effects of Lutein in Retinitis Pigmentosa
Study Type
Interventional
2. Study Status
Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2002 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
5. Study Description
Brief Summary
Phase I/II double-masked, randomized, placebo-controlled, cross-over trial to determine effects of lutein on vision in retinitis pigmentosa, including safety and effective dosage assessment
Detailed Description
Retinitis pigmentosa (RP) is a group of congenital retinal degenerations affecting over 100,000 individuals in the US, characterized by nightblindness, gradual loss of peripheral vision, and eventually total vision loss. Despite surgical and medical efforts it has not been possible to slow down, let alone reverse, the process of photoreceptor degeneration in RP. However, a recent patient-initiated pilot study demonstrated that RP patients may respond to a nutrition supplement (lutein) with a modest, but statistically significant gain in visual acuity and central visual field area; demonstration of these effects relied critically on frequent home vision tests using a letter chart on the screen of a personal computer and a wall chart to measure the central visual field. Supporting the reliability of the data was a highly significant correlation between eye color and vision changes; eye color has earlier been shown to influence macular pigment changes following lutein supplementation.
At this state, a study of long-term lutein benefits would be costly and, without placebo-controlled pilot data, premature. We are proposing to prepare for a long-term clinical trial through an exploratory study, investigating the effects of lutein and creating PC-based home vision tests. In the initial 6 months of the study, we will develop and adapt standard clinical vision tests for use on a personal computer, and recruit two study groups: 1) 42 RP patients to study the effects of lutein on vision, using placebo and 20 dosages in a randomized, double-masked crossover design (Latin Square, 2x16 weeks), testing for possible adverse effects through serum hepatic panels every 4-6 weeks, and measuring compliance through baseline and end-value serum carotenoid tests and frequent macular pigment density tests; 2) 31 other volunteers (10 normally signed, 21 RP patients) who, along with the first group, will monitor their vision every 1-2 weeks at home using the PC-based tests. Results will be validated against those obtained with standards tests during multiple visits to our center.
The results and tools produced by this study will enable a long-term lutein supplementation trial with vision as its principal outcome measure, and the study can serve as a model for other supplement trials. Moreover, by virtue of the PC-based home vision tests developed as part of this study, such future trials may, under proper safeguards, enroll remote participants who would download test software, perform frequent outcome tests at home, submit test results via e-mail, and be examined periodically by local physicians to detect potential adverse effects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinitis Pigmentosa
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lutein (10 or 30 mg/day) capsules
10. Eligibility
Facility Information:
Facility Name
Johns Hopkins Wilmer Eye Institute, Lions Vision Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16759390
Citation
Bahrami H, Melia M, Dagnelie G. Lutein supplementation in retinitis pigmentosa: PC-based vision assessment in a randomized double-masked placebo-controlled clinical trial [NCT00029289]. BMC Ophthalmol. 2006 Jun 7;6:23. doi: 10.1186/1471-2415-6-23.
Results Reference
derived
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Effects of Lutein in Retinitis Pigmentosa
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