Clinical Trial of Lutein for Patients With Retinitis Pigmentosa Receiving Vitamin A

December 12, 2013 updated by: National Eye Institute (NEI)

Randomized Clinical Trial for Retinitis Pigmentosa

The purpose of this trial is to determine whether lutein in addition to vitamin A will slow the course of retinitis pigmentosa.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 mid-peripheral visual field in adolescence. As the condition progresses, they lose far peripheral visual field. Most patients have reductions in central vision by 60 years if left untreated. Vitamin A palmitate, 15,000 International Units (IU)/d and an omega-3 rich diet have been shown to slow the progression of this condition among adults with the typical forms.(see Archives of Ophthalmology,111:761-772,1993 ; Archives of Ophthalmology 122: 1306-1314, 2004; Archives of Ophthalmology 130(6):701-711,2013).

The present study was a randomized, controlled, double-masked trial with a planned duration of 5 years.Two hundred and forty adults with the typical forms of RP were assigned to either lutein 12mg/d or a control group. Patients in both groups received 15,000 IU/day of vitamin A palmitate in addition to the supplement under study. Participants agreed not to know the contents of the supplement or their group assignment until the end of the trial. The main outcome measurement was the total point score for the 30-2 program of the Humphrey Field analyzer (HFA). In addition,the total point score for the 60-4 program ,the total point score of the 30-2 and 60-4 programs combined, computer-averaged 30-Hz cone Electroretinogram (ERG) amplitude and Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity were measured annually as secondary endpoints.

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 3

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
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Berman Gund Laboratory for the Study of Retinal Degenerations, Harvard Medical School ,Massachusetts Eye & Ear Infirmary

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

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Ocular Criteria

  • RP, typical forms(i.e. elevated final dark adaptation threshold,retinal arteriolar narrowing,and reduced and delayed full-field ERGs).
  • Best-corrected visual acuity 20/100 or better
  • HFA program 30-2 total point score >= 250 decibels(dB)to a size V white test light
  • No confounding ocular disease such as glaucoma,uveitis,diabetic retinopathy,posterior subcapsular cataract more than 11% of total lens area (ie equivalent to P3 on Lens Opacity Classification System III)and pupil diameter after dilation less than 6 mm.

Dietary Criteria

  • Fruit and vegetable intake < 10 servings/d
  • Spinach or kale intake < 1 serving/d, i.e. <1/2 cup of cooked spinach or kale per day
  • Dietary lutein intake <=5.4 mg/d as estimated from food frequency questionnaire
  • No intake of cod liver oil or omega-3 capsules
  • Dietary preformed vitamin A intake <= 10,000 IU/d
  • Supplement intake <= 5,000 IU/d of Vitamin A and <= 30 IU/d of Vitamin E
  • Consumption <= 3 alcoholic beverages/d

Medical and other criteria

  • Age 18-60 y
  • Body mass index < 40 and weight >= 5th percentile for age,gender,and height
  • Serum retinol level <= 100 micrograms/deciliter and serum retinyl ester level <= 380 nanomoles/Liter
  • Serum cholesterol < 300 micrograms/deciliter and serum triglyceride level <400 micrograms/deciliter
  • No clinically significant abnormality on blood cell count, glucose level, blood urea nitrogen level, serum lipid panel results or serum liver function profile.
  • Not pregnant or planning to become pregnant
  • Not smoking currently
  • Agreed not to know tablet content or course of condition until the end of the trial.
  • No other disease which might affect absorption or metabolism of lutein or vitamin A.
  • Only one patient per family was accepted into the study.

Exclusion Criteria:

  • Women who are pregnant or planning to become pregnant (Vitamin A supplements can increase the risk of birth defects.)
  • Current participation in another clinical trial for RP
  • Patients with atypical forms such as paravenous RP, pericentral RP, sector RP,unilateral RP,Refsum disease, Bardet-Biedl syndrome, retinitis punctata albescens and cone-rod dystrophy were excluded as were patients with RP and profound congenital deafness.

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: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lutein plus 15,000 IU/d Vitamin A
Daily intake of 12mg of Lutein plus 15,000 IU/d of Vitamin A palmitate
Drug: Lutein
12mg/d
Placebo Comparator: Control plus 15,000 IU/d Vitamin A
Daily intake of cornstarch control plus 15,000 IU/d Vitamin A palmitate
Dietary supplement: Cornstarch control
Daily intake of cornstarch control plus 15,000 IU/d Vitamin A palmitate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central Visual Field (vf) Change Assessed Using the 30-2 Program of the Humphrey Field Analyzer (HFA).
Time Frame: assessed at each of 4 annual visits after baseline
Sum of visual field sensitivity readings in decibel(dB) to a size V target out to the 30 degree meridian in each direction of the visual field. The value presented represents annual change in dB over 4 years.
assessed at each of 4 annual visits after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mid-peripheral Field Change Assessed With the 60-4 Program of the Humphrey Field Analyzer.
Time Frame: assessed at each of 4 annual visits after baseline
Sum of visual field sensitivity readings in dB to a size V target from the 30 degree meridian to the 60 degree meridian in each direction of the visual field. The value presented represents annual change in dB over 4 years.
assessed at each of 4 annual visits after baseline
Total Field Change Assessed by the Combined 30-2 and 60-4 Programs of the Humphrey Field Analyzer.
Time Frame: assessed at each of 4 annual visits after baseline
Sum of visual field sensitivity readings in dB to a size V target obtained with the 30-2 and 60-4 programs of the Humphrey Field Analyzer combined for those patients on whom both measures were available.
assessed at each of 4 annual visits after baseline
Annual Change in 30 Hertz(Hz)Electroretinogram(ERG )Amplitude in Natural Log (ln) Microvolts/yr Over a 4 Year Period.
Time Frame: assessed at each of 4 annual visits after baseline
Computer averaged 30 Hz ERG amplitudes in microvolts for those with initial amplitudes of >= 0.68 microvolts. Presented on the ln scale.
assessed at each of 4 annual visits after baseline
Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity
Time Frame: assessed at each of 4 annual visits after baseline
Annual change in number of letters read.
assessed at each of 4 annual visits after baseline

Collaborators and Investigators

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

Sponsor

National Eye Institute (NEI)

Investigators

  • Study Chair: Eliot L Berson, MD, Harvard Medical School (HMS and HSDM)

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

July 1, 2003

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

June 27, 2006

First Submitted That Met QC Criteria

June 27, 2006

First Posted (Estimate)

June 29, 2006

Study Record Updates

Last Update Posted (Estimate)

January 31, 2014

Last Update Submitted That Met QC Criteria

December 12, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEI-126

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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