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The influence of oral lutein supplementation on visual function and eye health in healthy school-aged children

The influence of oral lutein supplementation on visual function and eye health in healthy school-aged children

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100376
Enrollment
Unknown
Registered
2025-04-08
Start date
2024-04-30
Completion date
Unknown
Last updated
2025-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

control group:Blank control
Test group:Eye protection nutritional supplement (lutein)

Sponsors

Nanjing Tongren Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 10 Years

Inclusion criteria

Inclusion criteria: 1. Age 6-10 years old; 2. The guardian and the child can cooperate with the intervention, investigation and follow-up, and be conscious; 3. Best corrected visual acuity >= Snellen20/20; 4. No history of eye trauma and ocular disease; 5. No ocular structural diseases and abnormalities; 6. No organic diseases of the optic nerve and visual central system were found; 7. No other eye diseases; 8. The subject child already has pseudomyopia, insufficient farsightedness reserve, or the guardian believes that there are significant eye health problems. 9. The guardian and the child sign the informed consent form in writing. 10. Have not taken lutein supplements before.

Exclusion criteria

Exclusion criteria: 1. Suffering from eye diseases that affect vision or refractive error (such as lens damage diseases such as cataract, glaucoma, macular degeneration, corneal lesions, pigmentitis, retinal detachment, severe vitreous opacity, etc.). 2. Concomitant ocular or systemic infectious disease or concomitant active ocular inflammatory disease; 3. Recent (within 6 months) cataract or retinal surgery; 4. Take phenothiazines, chloroquine and other photosensitizing drugs; 5. Have taken lutein or zeaxanthin supplements within the past six months; 6. Those who are not suitable for enrollment in this study as assessed by the investigator.

Design outcomes

Primary

MeasureTime frame
acular pigment optical densit;Macular foveal thickness;Axial eye;Contrast sensitivity;

Secondary

MeasureTime frame
vision;intraocular pressure;diopter;

Countries

Chain

Contacts

Public ContactZixiu Zhou

Nanjing Tongren Hospital

zhouzx@njtrh.org+86 180 6880 0989

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026