the Effects of Fish Oil Supplements on Choroidal Thicknes... | NCT06877494

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

NCT06877494

Sponsor

Shanghai Eye Disease Prevention and Treatment Center

Status

Completed

Last Update Posted

Mar 14, 2025Actual

Enrollment

38Actual

Phase

Phase 2

Conditions

Fish Oils

Interventions

fish oil

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 21, 2024Actual

Primary Completion Date

Oct 21, 2024Actual

Completion Date

Dec 2, 2024Actual

First Submitted Date

Mar 11, 2025

First Submission Date that Met QC Criteria

Mar 11, 2025

First Posted Date

Mar 14, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2025

Last Update Posted Date

Mar 14, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

9 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Eye Disease Prevention and Treatment Center		Shanghai	Shanghai Municipality	20041	China

ID	Term
D009821	Oils
D008055	Lipids