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Screen time solution? gummy vitamins may boost Kids' eyes and brain

NCT ID NCT07355725

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether Lutemax 2020 gummies, containing lutein and zeaxanthin, could improve vision and cognitive performance in children aged 5 to 12 who spend at least 4 hours daily on digital devices. Sixty children were randomly assigned to receive either the supplement or a placebo for about 6 months. Researchers measured changes in macular pigment density, visual processing speed, and contrast sensitivity to see if the supplement helped counteract the effects of heavy screen time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lutemax 2020 (lutein and zeaxanthin) gummies
What this could lead to
If it works, this could point toward a simple supplement to help protect children's eyesight and mental focus from too much screen time.
What could go wrong
This is a small, completed study with only 60 children, so results may not apply to everyone. Dietary supplements often show modest effects, and the placebo effect could play a role.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

60 people

The number who actually took part.

Started

Jul 2022

Finished

Jan 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 12 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Children (Male/female) of ≥5 and ≤12 years of age 2. Participants with BMI equal to or greater than the 5th percentile and less than the 85th percentile for age, gender, and height 3. Participants with screen time i.e., exposure to digital devices for minimum 4 hours per day 4. Participants who agree to maintain their usual dietary habits throughout the trial period. 5. Participants who agree to maintain their usual level of activity throughout the trial period 6. Participants demonstrates understanding of the study and willingness to participate as evidenced by participant's parents or legally authorized representative's by giving voluntary written informed consent. 7. Participants willing and able to understand and comply with the requirements of the study, consume the study IP as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study Exclusion Criteria: 1. Participants ˂ 5 or ˃ 12 years of age 2. Participants having hypersensitivity or history of allergy to the study product or any of its ingredients 3. Participants suffering from a metabolic disorder (uncontrolled diabetes, uncontrolled thyroidal condition) and/or from severe chronic disease (cancer, renal failure, HIV, immunodeficiency, hepatic or biliary disorders, uncontrolled cardiac disease) or from a disease found to be inconsistent with the conduct of the study by the investigator 4. Participants having a current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder that would make the subject unlikely to fully complete the study or any condition that presents undue risk from the study product or procedures in the opinion of the investigator 5. Participants with a recent history (3 months) of serious infections, injuries and/ or surgeries 6. Participants consuming carotenoid supplements including lutein and zeaxanthin, anti-oxidant supplements, iron, calcium and/or other nutritional supplements and/ or health food drinks on a regular basis (more than 3 times a week, in the recommended dosage) in the last 1 month prior to screening visit 7. Participants who have been treated with any investigational drug or investigational device within a period of 3 months prior to study entry 8. Participant with any other condition, which as per the investigator would jeopardize the outcome of the trial 9. Participant who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Sanjeevini Netralaya

    Bangalore, Karnataka, 560001, India

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Other studies related to the condition(s) this trial covers.