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

Primary Purpose

Retinitis Pigmentosa

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Lutein
Cornstarch control
Sponsored by
National Eye Institute (NEI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinitis Pigmentosa focused on measuring Retinitis Pigmentosa, Inherited Retinal Degeneration

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lutein plus 15,000 IU/d Vitamin A

Control plus 15,000 IU/d Vitamin A

Arm Description

Daily intake of 12mg of Lutein plus 15,000 IU/d of Vitamin A palmitate

Daily intake of cornstarch control plus 15,000 IU/d Vitamin A palmitate

Outcomes

Primary Outcome Measures

Central Visual Field (vf) Change Assessed Using the 30-2 Program of the Humphrey Field Analyzer (HFA).
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.

Secondary Outcome Measures

Mid-peripheral Field Change Assessed With the 60-4 Program of the Humphrey Field Analyzer.
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.
Total Field Change Assessed by the Combined 30-2 and 60-4 Programs of the Humphrey Field Analyzer.
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.
Annual Change in 30 Hertz(Hz)Electroretinogram(ERG )Amplitude in Natural Log (ln) Microvolts/yr Over a 4 Year Period.
Computer averaged 30 Hz ERG amplitudes in microvolts for those with initial amplitudes of >= 0.68 microvolts. Presented on the ln scale.
Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity
Annual change in number of letters read.

Full Information

First Posted
June 27, 2006
Last Updated
December 12, 2013
Sponsor
National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT00346333
Brief Title
Clinical Trial of Lutein for Patients With Retinitis Pigmentosa Receiving Vitamin A
Official Title
Randomized Clinical Trial for Retinitis Pigmentosa
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Eye Institute (NEI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinitis Pigmentosa
Keywords
Retinitis Pigmentosa, Inherited Retinal Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lutein plus 15,000 IU/d Vitamin A
Arm Type
Experimental
Arm Description
Daily intake of 12mg of Lutein plus 15,000 IU/d of Vitamin A palmitate
Arm Title
Control plus 15,000 IU/d Vitamin A
Arm Type
Placebo Comparator
Arm Description
Daily intake of cornstarch control plus 15,000 IU/d Vitamin A palmitate
Intervention Type
Drug
Intervention Name(s)
Lutein
Intervention Description
12mg/d
Intervention Type
Dietary Supplement
Intervention Name(s)
Cornstarch control
Intervention Description
Daily intake of cornstarch control plus 15,000 IU/d Vitamin A palmitate
Primary Outcome Measure Information:
Title
Central Visual Field (vf) Change Assessed Using the 30-2 Program of the Humphrey Field Analyzer (HFA).
Description
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.
Time Frame
assessed at each of 4 annual visits after baseline
Secondary Outcome Measure Information:
Title
Mid-peripheral Field Change Assessed With the 60-4 Program of the Humphrey Field Analyzer.
Description
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.
Time Frame
assessed at each of 4 annual visits after baseline
Title
Total Field Change Assessed by the Combined 30-2 and 60-4 Programs of the Humphrey Field Analyzer.
Description
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.
Time Frame
assessed at each of 4 annual visits after baseline
Title
Annual Change in 30 Hertz(Hz)Electroretinogram(ERG )Amplitude in Natural Log (ln) Microvolts/yr Over a 4 Year Period.
Description
Computer averaged 30 Hz ERG amplitudes in microvolts for those with initial amplitudes of >= 0.68 microvolts. Presented on the ln scale.
Time Frame
assessed at each of 4 annual visits after baseline
Title
Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity
Description
Annual change in number of letters read.
Time Frame
assessed at each of 4 annual visits after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eliot L Berson, MD
Organizational Affiliation
Harvard Medical School (HMS and HSDM)
Official's Role
Study Chair
Facility Information:
Facility Name
Berman Gund Laboratory for the Study of Retinal Degenerations, Harvard Medical School ,Massachusetts Eye & Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20385935
Citation
Berson EL, Rosner B, Sandberg MA, Weigel-DiFranco C, Brockhurst RJ, Hayes KC, Johnson EJ, Anderson EJ, Johnson CA, Gaudio AR, Willett WC, Schaefer EJ. Clinical trial of lutein in patients with retinitis pigmentosa receiving vitamin A. Arch Ophthalmol. 2010 Apr;128(4):403-11. doi: 10.1001/archophthalmol.2010.32.
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Clinical Trial of Lutein for Patients With Retinitis Pigmentosa Receiving Vitamin A

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