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Effects of Lutein in 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. Identifier: NCT00029289
Recruitment Status : Completed
First Posted : January 10, 2002
Last Update Posted : August 18, 2006
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

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

Condition or disease Intervention/treatment Phase
Retinitis Pigmentosa Drug: Lutein (10 or 30 mg/day) capsules Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Effects of Lutein in Retinitis Pigmentosa
Study Start Date : April 2001
Study Completion Date : October 2002

Resource links provided by the National Library of Medicine

Drug Information available for: Lutein

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult

Information from the National Library of Medicine

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Please refer to this study by its identifier (NCT number): NCT00029289

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United States, Maryland
Johns Hopkins Wilmer Eye Institute, Lions Vision Center
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00029289     History of Changes
Other Study ID Numbers: R21AT000292-01 ( U.S. NIH Grant/Contract )
First Posted: January 10, 2002    Key Record Dates
Last Update Posted: August 18, 2006
Last Verified: August 2006
Additional relevant MeSH terms:
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Retinitis Pigmentosa
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn