← Back to Search

Carotenoid

Lutein Supplementation for Eye Strain in Children

N/A

Waitlist Available

Research Sponsored by Northcentral University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age of 8 to 16 years

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial will test whether lutein supplements can improve cognitive and visual outcomes in children who spend a lot of time looking at screens.

Who is the study for?

This trial is for healthy children aged 8 to 16 who spend at least 4 hours daily on digital screens. They must be in good health overall, as reported by a guardian, and not currently taking supplements with lutein or zeaxanthin.Check my eligibility

What is being tested?

The study tests if taking lutein supplements for six months can improve eye and brain function in kids exposed to lots of screen time. It's a controlled test where some get lutein and others get a placebo without knowing which one they're getting.See study design

What are the potential side effects?

Lutein is generally considered safe but could cause side effects like skin yellowing or stomach pain. Since it's being compared to a placebo, any additional side effects will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 8 and 16 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Macular Pigment Optical Density - haidinger's brushes

Macular Pigment Optical Density - heterochromatic flicker photometry

Secondary outcome measures

Digital Eye strain change from baseline

Sleep score change from baseline

Verbal Fluency

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: LuteinExperimental Treatment1 Intervention

5 mg lutein gummy taken daily for 180 days

Group II: PlaceboPlacebo Group1 Intervention

0 mg lutein gummy taken daily for 180 days

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

lutein

2007

N/A

~100

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northcentral UniversityLead Sponsor

Patrick McNamara, PhDStudy ChairNorthcentral University

Media Library

lutein (Carotenoid) Clinical Trial Eligibility Overview. Trial Name: NCT05314647 — N/A

Cognitive Impairment Research Study Groups: Placebo, Lutein

Cognitive Impairment Clinical Trial 2023: lutein Highlights & Side Effects. Trial Name: NCT05314647 — N/A

lutein (Carotenoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05314647 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would I be eligible to partake in this trial?

"This research study has 70 slots for applicants aged between 8 to 16 years of age, who have asthenopia and at least 4 hours of daily digital screen usage. Additionally, participants must be certified as generally healthy by their guardian."

Answered by AI

Does this research study accept participants aged 35 or older?

"This study is open to children from 8 years old up until the age of 16."

Answered by AI

Is there availability for participants to join the experiment?

"According to clinicaltrials.gov, the posting for this medical study is no longer active and the trial has not recruited any new patients since April 3rd 2022. However, 330 other trials are actively recruiting volunteers at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Lutein Supplementation in Healthy Children

Brenda Fonseca 2023. "Lutein Supplementation in Healthy Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05314647.