The Effects of Lutein and Zeaxanthin Supplementation on Vision in Patients With Albinism
NCT ID: NCT02200263
Last Updated: 2018-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
10 participants
INTERVENTIONAL
2014-11-30
2018-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The functionality and the clinical findings are diverse (the phenotype), and no direct correlation has been established to the underlying mutations (genotype).
The common ocular phenotype includes iris transillumination, foveal hypoplasia, nystagmus, reduced visual acuity, refractive error, photosensitivity and abnormal development of the visual pathways with characteristic abnormal routing of ganglion cell axons in the chiasma, resulting in abnormal visually evoked potentials. Current treatment options are limited to optical methods and low vision aids.
The mechanism of melanin pigment formation in the RPE cells and its role in the visual pathways and structures development is not completely understood, but a correlation was found between the amount of fundus pigmentation and visual function in albino patients. The absent pigmentation within the retinal pigment epithelium (RPE) may thus contribute to visual performance deficits.
The macular pigment (MP) consists of two main carotenoids, lutein and zeaxanthin, which are concentrated in the macular region of the retina. MP is hypothesized to function via a protective mechanism by absorbing blue light incident on the retina thereby reducing oxidative damage to the underlying photoreceptors. It is also thought to improve visual function via reduction of chromatic aberration and glare. It is currently unclear as to how the variability in macular pigment optical density (MPOD) affects congenital retinal conditions. The MP would, however, be a hypothetical and good candidate to improve visual performance - simply by increasing pigmentation, reducing light scatter and thus glare sensitivity.
As this pigment is not produced in the retina, but is absorbed via diet, it can be manipulated by alteration in diet and supplementation thereby providing potential therapy for retinal diseases. It is however necessary first to see if MPOD levels are measurable in this disorder before dietary advice can be provided after completion of the LUVIA study. Further to this, evaluation of both the structural and functional properties of the retina will provide greater insight into the possible function of MP in this retinal disease including whether supplementation would be of benefit.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lutein plus Zeaxanthin
Participants randomized to this arm will receive 20 mg of Lutein (L) plus 20 mg of Zeaxanthin (Z) per day: Two pills (10 mg L+ 10 mg Z per pill) for the duration of one year.
Lutein plus Zeaxanthin
dose: two softgels once a day with a meal
Placebo softgels
Participants randomized to this arm will receive two pills per day of placebo-gels corresponding to the active compound in look and feel for the duration of one year
Placebo
two softgels once-daily with a meal
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lutein plus Zeaxanthin
dose: two softgels once a day with a meal
Placebo
two softgels once-daily with a meal
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Clinical and/or genetic diagnosis of ocular or oculocutaneous albinism
* Ocular media allowing acceptable visualization of the retina.
* Ocular media allowing acceptable quality of the ocular coherence tomography (OCT) and/or fundus autofluorescence (FAF) scans.
* At least one reliable central macular pigment optical density (MPOD) measurement captured on the enrollment visit in at least one eligible eye
* Best corrected visual acuity of 20/200 or better in one or both eligible eyes (eyes that confirmed to be eligible by the MPOD testing).
Exclusion Criteria
* Pregnant or planning to become pregnant
* Evidence of present or past retinal macular condition other than congenital foveal hypoplasia
* History of gastrointestinal disease that would interfere with absorption of lutein and zeaxanthin
* Participation in a clinical trial requiring visual testing or administration of a drug (marketed or investigational) within 60 days before entry in the study (the day informed consent is signed)
* Inability to communicate or cooperate with the investigator due to cognitive impairment or poor general health
* Any other condition which, in the opinion of the investigators, is likely to interfere with the successful collection of the measures required for the study
12 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Clark Charitable Foundation Inc.
OTHER
Johns Hopkins University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Neil Bressler, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Mary E. Frey
Role: STUDY_DIRECTOR
Johns Hopkins University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Wilmer Eye Institute
Baltimore, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NA_00088335
Identifier Type: -
Identifier Source: org_study_id