NCT00029289

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Apr 2001

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2001

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 10, 2002

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2002

Completed
Last Updated

August 18, 2006

Status Verified

August 1, 2006

First QC Date

January 9, 2002

Last Update Submit

August 16, 2006

Conditions

Interventions

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Wilmer Eye Institute, Lions Vision Center

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

  • Bahrami H, Melia M, Dagnelie G. Lutein supplementation in retinitis pigmentosa: PC-based vision assessment in a randomized double-masked placebo-controlled clinical trial [NCT00029289]. BMC Ophthalmol. 2006 Jun 7;6:23. doi: 10.1186/1471-2415-6-23.

MeSH Terms

Conditions

Retinitis Pigmentosa

Interventions

Lutein

Condition Hierarchy (Ancestors)

Eye Diseases, HereditaryEye DiseasesRetinal DystrophiesRetinal DegenerationRetinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

XanthophyllsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological Factors

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
NIH

Study Record Dates

First Submitted

January 9, 2002

First Posted

January 10, 2002

Study Start

April 1, 2001

Study Completion

October 1, 2002

Last Updated

August 18, 2006

Record last verified: 2006-08

Locations