A Randomized Placebo-controlled Trial to Investigate the Effect of Lutein and Zeaxanthin Supplementation on Macular Pigment and Visual Function in Albinism - LUtein for VIsion in Albinism (LUVIA)
The Effects of Lutein and Zeaxanthin Supplementation on Vision in Patients With Albinism
Sponsors
Source
Johns Hopkins University
Oversight Info
Has Dmc
Yes
Brief Summary
The LUVIA study is a randomized placebo-controlled trial designed to investigate the effects
of lutein and zeaxanthin supplementation on macular pigment and visual function in ocular or
oculocutaneous albinism. Lutein and zeaxanthin supplementation will be compared to a placebo
(no treatment) gel pill over the period of 12 months, with study visits approximately every 3
months for the first year and a final visit 18 months after enrollment.
Detailed Description
Ocular and oculocutaneous albinism represent a spectrum of disorders with absent or
significantly diminished amount of melanin either across different body tissues - skin, hair,
eye (Oculocutaneous Albinism 1 and 2), or exclusively in eye tissues only (Ocular Albinism 1)
.
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.
Overall Status
Completed
Start Date
2014-11-01
Completion Date
2018-04-01
Primary Completion Date
2018-04-01
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Macular pigment optical density (MPOD) |
12 months |
Secondary Outcome
Measure |
Time Frame |
|
Contrast acuity |
12 months |
|
Visual field, fixation and central retinal sensitivity |
12 months |
|
Bioavailability profile of Lutein and Zeaxanthin |
12 months |
|
Evaluation of the diversity of microstructural central retinal abnormalities |
12 months |
|
Best Corrected Visual Acuity (BCVA) |
12 months |
Enrollment
10
Conditions
Intervention
Intervention Type
Dietary Supplement
Intervention Name
Description
dose: two softgels once a day with a meal
Arm Group Label
Lutein plus Zeaxanthin
Other Name
EyePromise® Lutein + Zeaxanthin (ZeaVision, LLC)
Intervention Type
Dietary Supplement
Intervention Name
Description
two softgels once-daily with a meal
Arm Group Label
Placebo softgels
Other Name
placebo softgels
Eligibility
Criteria
Inclusion Criteria:
- Age of 12 years old and older
- 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:
- Persons taking lutein and/or zeaxanthin supplements over the past 6 months
- 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
Gender
All
Minimum Age
12 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Neil Bressler, MD |
Principal Investigator |
Johns Hopkins University |
|
Mary E. Frey |
Study Director |
Johns Hopkins University |
Location
Facility |
|
Wilmer Eye Institute Baltimore Maryland 21287-9277 United States |
Location Countries
Country
United States
Verification Date
2018-12-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Arm Group
Arm Group Label
Lutein plus Zeaxanthin
Arm Group Type
Experimental
Description
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.
Arm Group Label
Placebo softgels
Arm Group Type
Placebo Comparator
Description
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
Firstreceived Results Date
N/A
Acronym
LUVIA
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Study First Submitted
July 23, 2014
Study First Submitted Qc
July 24, 2014
Study First Posted
July 25, 2014
Last Update Submitted
December 27, 2018
Last Update Submitted Qc
December 27, 2018
Last Update Posted
December 28, 2018
ClinicalTrials.gov processed this data on December 12, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.