Effects of Lutein in Retinitis Pigmentosa

August 16, 2006 updated by: National Center for Complementary and Integrative Health (NCCIH)
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins Wilmer Eye Institute, Lions Vision Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Complementary and Integrative Health (NCCIH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Study Completion

October 1, 2002

Study Registration Dates

First Submitted

January 9, 2002

First Submitted That Met QC Criteria

January 9, 2002

First Posted (Estimate)

January 10, 2002

Study Record Updates

Last Update Posted (Estimate)

August 18, 2006

Last Update Submitted That Met QC Criteria

August 16, 2006

Last Verified

August 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21AT000292-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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