MedTrace Logo

The Effects of Lutein and Zeaxanthin Supplementation on Vision in Patients With Albinism

NCT02200263 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-12-28

No results posted yet for this study

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.

Conditions

  • Ocular Albinism (OA)
  • Oculocutaneous Albinism (OCA)

Interventions

DIETARY_SUPPLEMENT

Lutein plus Zeaxanthin

dose: two softgels once a day with a meal

DIETARY_SUPPLEMENT

Placebo

two softgels once-daily with a meal

Sponsors & Collaborators

Principal Investigators

  • Neil Bressler, MD · Johns Hopkins University

  • Mary E. Frey · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2018-04-30
Completion
2018-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02200263 on ClinicalTrials.gov