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

Exploratory Study on 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.

Study Overview

• Status: Completed
• Conditions: Fish Oils
• Intervention / Treatment: Dietary supplement: fish oil

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 20041
      • Shanghai Eye Disease Prevention and Treatment Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Twice a day, with one dose of DHA 300mg: EPA 60mg, for a continuous intervention of 90 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axial length	the change of axial length	15±2 days, 30±2 days, and 90±2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in equivalent spherical	change in equivalent spherical in both eyes	15±2 days, 30±2 days, and 90±2 days

Collaborators and Investigators

• Sponsor: Shanghai Eye Disease Prevention and Treatment Center

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2024
• Primary Completion (Actual): October 21, 2024
• Study Completion (Actual): December 2, 2024

Study Registration Dates

• First Submitted: March 11, 2025
• First Submitted That Met QC Criteria: March 11, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: YFZXYDK20240115

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No