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

NCT06877494 | Completed Phase 2 DMC

• 1 other identifier: YFZXYDK20240115
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fish Oils

Outcome Measures

Primary Outcomes (1)

• Axial length

  the change of axial length

  15±2 days, 30±2 days, and 90±2 days

Secondary Outcomes (1)

• change in equivalent spherical

  15±2 days, 30±2 days, and 90±2 days

Study Arms (2)

no-treatment control group

NO INTERVENTION

No intervention measures are applied

fish oil supplement group

EXPERIMENTAL

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

Dietary Supplement: fish oil

Interventions

fish oil DIETARY_SUPPLEMENT

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

fish oil supplement group

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Eye Disease Prevention and Treatment Center: lead

Study Sites (1)

Shanghai Eye Disease Prevention and Treatment Center

Shanghai, Shanghai Municipality, 20041, China

Location

MeSH Terms

Interventions

Fish Oils

Intervention Hierarchy (Ancestors)

Oils; Lipids

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 14, 2025
• Study Start: July 21, 2024
• Primary Completion: October 21, 2024
• Study Completion: December 2, 2024
• Last Updated: March 14, 2025

Record last verified: 2024-07

Locations

CN (1)