Status:
UNKNOWN
Effects of Lutein Supplementation on Cognition and MPOD in Multiple Sclerosis Patients-
Lead Sponsor:
University of Illinois at Urbana-Champaign
Collaborating Sponsors:
Division of Nutritional Sciences, University of Illinois at Urbana-Champaign
National Institutes of Health (NIH)
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-64 years
Phase:
NA
Brief Summary
The central hypothesis is that lutein supplementation will improve MPOD and cognition. Accordingly, the specific aims are to 1) to determine the process feasibility associated with participating in 4-...
Detailed Description
A two-group parallel design will be employed whereby participants will be randomly assigned to one of 2 groups. The supplementation doses 20mg/d (Group 1), and placebo (Group 2) will be consumed daily...
Eligibility Criteria
Inclusion
- 18-64.9 years
- Self-reported relapsing-remitting MS (RRMS) diagnosis
- Expanded Disability Status Scale (EDSS) score between 0-3.5
- Macular Pigment Optical Density at baseline (MPOD ≤0.35)
- Score ≤55 during the Symbol Digit Modalities Test (SDMT)
- 20/20 or corrected vision
- No presence of color blindness
- No history of age-related macular degeneration
- No history of epileptic seizures
Exclusion
- Under 18 years or over 64.9 years
- MS diagnosis other than RRMS
- Pregnancy
- Uncorrected vision
- Presence of color blindness
- PDDS score of 7 or more
- Prior diagnosis of age-related macular degeneration
- History of epileptic seizures
Key Trial Info
Start Date :
March 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04843813
Start Date
March 26 2021
End Date
March 1 2023
Last Update
April 15 2021
Active Locations (1)
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1
University of Illinois at Urbana-Champaign
Urbana, Illinois, United States, 61801