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Macular Pigment and Glare Disability (MP-GD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by University of Georgia.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Georgia
ClinicalTrials.gov Identifier:
NCT00909090
First received: May 22, 2009
Last updated: August 10, 2011
Last verified: May 2011
  Purpose

The purpose of this study is:

I. To measure MP optical density (MPOD) spatial profiles in two groups (experimental and placebo) of 50 subjects each (N = 100), during an L + Z supplementation period of 12 months.

II. To test the hypothesis that increases in MP (via 12 mg daily L + Z supplementation) will result in significantly improved visual performance under disability glare conditions.

III. To test the hypothesis that increases in MP (via 12 mg daily L + Z supplementation) will result in significantly reduced photostress recovery times.

IV. To test the hypothesis that increases in MP (via 12 mg daily L + Z supplementation) will result in improved contrast enhancement.


Condition Intervention Phase
Glare Disability in Healthy Subjects
Dietary Supplement: lutein and zeaxanthin supplements
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Lutein and Zeaxanthin Upon MPOD and Its Effects Upon Glare Disability, Photostress Recovery, and Contrast Enhancement in Healthy Subjects: A Randomized, Double-blind Placebo-controlled Study

Resource links provided by NLM:


Further study details as provided by University of Georgia:

Primary Outcome Measures:
  • Disability glare and contrast enhancement thresholds, photostress recovery times [ Time Frame: every three months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: LZ supplement
Lutein and zeaxanthin supplementation (12mg/day) will be compared to a placebo control for a one year duration.
Dietary Supplement: lutein and zeaxanthin supplements
12 mg taken daily for one year
Other Name: The LZ supplement will be provided by DSM and Kemin
Placebo Comparator: Placebo
Lutein and zeaxanthin supplementation (12mg/day) will be compared to a placebo control for a one year duration.
Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Gender: male or female
  • Age: 20 - 40 years
  • BMI: 20-30
  • No anticipated changes in dieting habits (as relevant to xanthophyll intake).
  • No anticipated surgical procedures.
  • Assessed as healthy, based on a pre-study examination including medical history, physical examination, and clinical laboratory. The examination will be performed by an MD or a Nurse Practitioner.
  • Willingness and ability to give written informed consent and willingness and ability to comply with the study requirements.
  • Corrected visual acuity (ETDRS): better than 20/60

Exclusion Criteria:

  • BMI <20 or >30
  • Age <20 or >40 years
  • Smokers
  • Current or history of relevant diseases (such as AMD)
  • Corrected visual acuity worse than 20/60
  • Inability to reliably perform MPOD measurements by HFP or any of the other ophthalmic tests of the study.
  • Any condition likely to interfere with normal gastro-intestinal absorption of xanthophylls.
  • Current use of xanthophyll containing supplements
  • Use of xanthophyll containing supplements in the past 6 months
  • Participation in any other study during last 1 month.
  • Blood donation during the last 3 months.
  • Known hypersensitivity or allergy to xanthophylls.
  • Regular intake of medications or supplements, which the principal investigator deems likely to confound the study outcomes.
  • Suspected lack of compliance with any requirements of the study.
  • Childbearing potential and unwillingness to refrain from acceptable anticonceptive measures (not including abstinence).
  • Current pregnancy or breast feeding
  • Any relevant abnormalities in the routine laboratory tests
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00909090

Locations
United States, Georgia
Vision Sciences Laboratory, UGA
Athens, Georgia, United States, 30602
Sponsors and Collaborators
University of Georgia
Investigators
Principal Investigator: Billy R Hammond, Ph.D. University of Georgia
  More Information

No publications provided by University of Georgia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Billy R. Hammond, Jr., Professor, PI, University of Georgia
ClinicalTrials.gov Identifier: NCT00909090     History of Changes
Other Study ID Numbers: UGA-2009-10141-1
Study First Received: May 22, 2009
Last Updated: August 10, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Georgia:
macular pigment
glare disability
lutein
photostress

ClinicalTrials.gov processed this record on November 20, 2014