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Completed

NCT Number: NCT06877494

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

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.

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Key information

Conditions

Fish Oils

Age range

6 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shanghai Eye Disease Prevention and Treatment Center

Shanghai, Shanghai Municipality, 20041, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Fish Oil

Dietary Supplement

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

Primary outcomes

  1. Axial length

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

    the change of axial length

Secondary outcomes

  1. change in equivalent spherical

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

    change in equivalent spherical in both eyes

Sponsors and collaborators

Lead sponsor

Shanghai Eye Disease Prevention and Treatment Center

Other

Registry information

Official study title

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

Acronym: FOS

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 14, 2025
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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