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

NCT ID: NCT06877494

Last Updated: 2025-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-21

Study Completion Date

2024-12-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fish Oils

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

no-treatment control group

No intervention measures are applied

Group Type NO_INTERVENTION

No interventions assigned to this group

fish oil supplement group

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

Group Type EXPERIMENTAL

fish oil

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

fish oil

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shanghai Eye Disease Prevention and Treatment Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Shanghai Eye Disease Prevention and Treatment Center

Shanghai, Shanghai Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

YFZXYDK20240115

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Fish Oil and Muscle Function
NCT01308957 COMPLETED NA