Effects of Lutein Supplementation on Cognition and MPOD in Multiple Sclerosis Patients-

Study Results

Results pending

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.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-26

Study Completion Date

2023-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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-month lutein supplementation trial; and 2) to investigate the scientific feasibility of 4-month daily lutein supplementation on biological markers of lutein status and cognitive function among persons with MS.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Lipoic Acid and Omega-3 Fatty Acids for Cognitive Impairment in Multiple Sclerosis

NCT02133664

Multiple Sclerosis Cognition

COMPLETED PHASE1/PHASE2

Natural Antioxidants in the Treatment of Multiple Sclerosis

NCT00010842

Multiple Sclerosis

COMPLETED PHASE1/PHASE2

Defining the Anti-inflammatory Role of Lipoic Acid in Multiple Sclerosis

NCT00997438

Multiple Sclerosis

COMPLETED PHASE1

Longitudinal Effect of Vitamin D3 Replacement on Cognitive Performance and MRI Markers in Multiple Sclerosis Patients

NCT03610139

Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Clinically Isolated Syndrome +2 more

UNKNOWN NA

Effect of Vitamin D Replacement on Immune Function and Cognition in MS Patients

NCT01952483

Multiple Sclerosis (MS)

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 by the participant for a 4-month period. Pre-test and follow-up measures of lutein status and cognitive function will be assessed at baseline and at 4-month follow-up via laboratory visits.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Sclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A 2-group parallel design will be employed to collect feasibility data on daily lutein supplementation over 4 months.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lutein

Group Type EXPERIMENTAL

Lutein

Intervention Type DIETARY_SUPPLEMENT

Participants will consume daily soft gels containing the lutein supplement.

Safflower Oil

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Participants will consume daily soft gels containing the safflower oil.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lutein

Participants will consume daily soft gels containing the lutein supplement.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Participants will consume daily soft gels containing the safflower oil.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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 Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No