Clinical Trial of Lutein for Patients With Retinitis Pigmentosa Receiving Vitamin A
Randomized Clinical Trial for Retinitis Pigmentosa
1 other identifier
interventional
240
1 country
1
Brief Summary
The purpose of this trial is to determine whether lutein in addition to vitamin A will slow the course of retinitis pigmentosa.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2003
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2003
CompletedFirst Submitted
Initial submission to the registry
June 27, 2006
CompletedFirst Posted
Study publicly available on registry
June 29, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedResults Posted
Study results publicly available
January 31, 2014
CompletedJanuary 31, 2014
December 1, 2013
5.4 years
June 27, 2006
June 18, 2012
December 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
assessed at each of 4 annual visits after baseline
Secondary Outcomes (4)
Mid-peripheral Field Change Assessed With the 60-4 Program of the Humphrey Field Analyzer.
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.
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.
assessed at each of 4 annual visits after baseline
Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity
assessed at each of 4 annual visits after baseline
Study Arms (2)
Lutein plus 15,000 IU/d Vitamin A
EXPERIMENTALDaily intake of 12mg of Lutein plus 15,000 IU/d of Vitamin A palmitate
Control plus 15,000 IU/d Vitamin A
PLACEBO COMPARATORDaily intake of cornstarch control plus 15,000 IU/d Vitamin A palmitate
Interventions
Daily intake of cornstarch control plus 15,000 IU/d Vitamin A palmitate
Eligibility Criteria
You may qualify if:
- 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
- +9 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Berman Gund Laboratory for the Study of Retinal Degenerations, Harvard Medical School ,Massachusetts Eye & Ear Infirmary
Boston, Massachusetts, 02114, United States
Related Publications (2)
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.
PMID: 20385935RESULTComander J, Weigel DiFranco C, Sanderson K, Place E, Maher M, Zampaglione E, Zhao Y, Huckfeldt RM, Bujakowska KM, Pierce E. Natural history of retinitis pigmentosa based on genotype, vitamin A/E supplementation, and an electroretinogram biomarker. JCI Insight. 2023 Aug 8;8(15):e167546. doi: 10.1172/jci.insight.167546.
PMID: 37261916DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Eliot L. Berson, M.D.
- Organization
- Harvard Medical School
Study Officials
- STUDY CHAIR
Eliot L Berson, MD
Harvard Medical School (HMS and HSDM)
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2006
First Posted
June 29, 2006
Study Start
July 1, 2003
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
January 31, 2014
Results First Posted
January 31, 2014
Record last verified: 2013-12