Lutein for Multiple Sclerosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Multiple SclerosisLutein - DietarySupplement
Eligibility
18 - 64
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether lutein supplements can improve eyesight and cognition in people with multiple sclerosis.

Eligible Conditions
  • Multiple Sclerosis

Treatment Effectiveness

Study Objectives

5 Primary · 0 Secondary · Reporting Duration: 4 months (baseline vs. follow-up)

Month 4
Attentional Accuracy
Attentional Processing Speed
Attentional Reaction Time
Attentional Resource Allocation
Macular Pigment Optical Density

Trial Safety

Side Effects for

Control Plus Vitamin A
1%Death
This histogram enumerates side effects from a completed 2008 Phase 3 trial (NCT00346333) in the Control Plus Vitamin A ARM group. Side effects include: Death with 1%.

Trial Design

2 Treatment Groups

Lutein
1 of 2
Safflower Oil
1 of 2

Experimental Treatment

Non-Treatment Group

60 Total Participants · 2 Treatment Groups

Primary Treatment: Lutein · Has Placebo Group · N/A

Lutein
DietarySupplement
Experimental Group · 1 Intervention: Lutein · Intervention Types: DietarySupplement
Safflower Oil
DietarySupplement
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DietarySupplement
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lutein
2016
Completed Phase 3
~550

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 4 months (baseline vs. follow-up)

Who is running the clinical trial?

National Institutes of Health Rehabilitation Research Resource to Enhance Clinical Trials (REACT)UNKNOWN
University of Illinois at Urbana-ChampaignLead Sponsor
169 Previous Clinical Trials
33,896 Total Patients Enrolled
14 Trials studying Multiple Sclerosis
603 Patients Enrolled for Multiple Sclerosis
Division of Nutritional Sciences, University of Illinois at Urbana-ChampaignUNKNOWN
1 Previous Clinical Trials
50 Total Patients Enrolled
Naiman Khan, PhDPrincipal Investigator - University of Illinois Urbana Champaign
University of Illinois at Urbana-Champaign
1 Previous Clinical Trials
288 Total Patients Enrolled

Eligibility Criteria

Age 18 - 64 · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with relapsing-remitting MS (RRMS).
You have an EDSS score between 0-3.5.
You have macular pigment optical density of less than 0.35.
You have a score of 55 or less on the Symbol Digit Modalities Test (SDMT).

Who else is applying?

What state do they live in?
Illinois100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
University of Illinois at Urbana-Champaign100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%