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CompletedNCT06877494FOSUpdated Mar 14, 2025

the Effects of Fish Oil Supplements on Choroidal Thickness and Blood Flow Perfusion in Children and Adolescents

A Phase 2 interventional study of fish oil in Fish Oils, sponsored by Shanghai Eye Disease Prevention and Treatment Center. Completed at 1 site in China. Open to participants aged 6 Years to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-14.

Sponsored by Shanghai Eye Disease Prevention and Treatment Center · Phase 2, Interventional, and Prevention

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Jul 2024, registered Mar 2025).
Phase
Phase 2
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
6 Years to 9 Years
Sex
All
01

Study summary

The goal of this clinical trial is to test the effect of fish oil supplement in terms of vision in children and adolescents. The main question it aims to answer is:

the differences in changes of choroidal thickness, choroidal blood flow, axial length, and visual acuity between the intervention group and the control group Participants will take the fish oil supplement. a baseline examination will be conducted, followed by follow-up visits at 15, 30, and 90 days after the start of the intervention.

02

Conditions studied

  • Fish Oils
03

In context

Lead sponsor

Shanghai Eye Disease Prevention and Treatment Center is the lead sponsor of 64 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 9 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Age range: 6-9 years old, gender unspecified;
  2. Equivalent spherical power after unilateral cycloplegic eye ranging from 0.75D to -0.5D, with astigmatism not exceeding 1.5D;
  3. Best corrected visual acuity of at least 1.0;
  4. Ability to sign an informed consent form with the presence and understanding of a parent or guardian.

Exclusion criteria

Exclusion Criteria:

  1. Allergy or intolerance to ω-3 PUFAs or cycloplegics;
  2. Strabismus, history of eye surgery (including strabismus correction surgery), other eye diseases, or systemic diseases;
  3. Currently using myopia prevention measures.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
38 participants (actual)

Study arms

  • No intervention
    no-treatment control group

    No intervention measures are applied

  • Experimental
    fish oil supplement group

    Twice a day, with one dose of DHA 300mg: EPA 60mg, for a continuous intervention of 90 days

    Dietary Supplement: fish oil

Interventions

  • Dietary supplementfish oil

    Twice a day, with one dose of DHA 300mg: EPA 60mg, for a continuous intervention of 90 days

06

What researchers measure

Primary outcomes

  1. Axial length

    the change of axial length

    Time frame: 15±2 days, 30±2 days, and 90±2 days

Secondary outcomes

  1. change in equivalent spherical

    change in equivalent spherical in both eyes

    Time frame: 15±2 days, 30±2 days, and 90±2 days

07

Study locations

1 site
  • Shanghai Eye Disease Prevention and Treatment Center
    Shanghai, Shanghai 20041, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06877494
Lead sponsor
Shanghai Eye Disease Prevention and Treatment Center
Responsible party
Sponsor
First posted
Mar 14, 2025
Start date
Jul 21, 2024
Primary completion
Oct 21, 2024
Completion
Dec 2, 2024
Last update
Mar 14, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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