Fish OilsPhase 2FOSNCT06877494
the Effects of Fish Oil Supplements on Choroidal Thickness and Blood Flow Perfusion in Children and Adolescents
A Phase 2 study testing fish oil in people with Fish Oils, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Fish Oils
- What is being tested?
- fish oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 21 Jul 2024to 2 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Eye Disease Prevention and Treatment Center
Shanghai, Shanghai Municipality, 20041
About this study
Official title: 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.
- Conditions
- Fish Oils
- Being tested
- fish oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fish oilDietary supplement
Twice a day, with one dose of DHA 300mg: EPA 60mg, for a continuous intervention of 90 days
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: fish oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial length
the change of axial length
Measured: 15±2 days, 30±2 days, and 90±2 days
Secondary outcomes (1)
change in equivalent spherical
change in equivalent spherical in both eyes
Measured: 15±2 days, 30±2 days, and 90±2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start21 Jul 2024
- Primary completion21 Oct 2024
- Study completion2 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fish OilsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06877494
- Sponsor's protocol ID
- YFZXYDK20240115
- Acronym
- FOS
- Status last verified
- Jul 2024
- First submitted
- 11 Mar 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on the Effects of Fish Oil Supplements on Choroidal Thickness and Blood Flow Perfusion in Children and Adolescents
- ClinicalTrials.gov ID
- NCT06877494
- Acronym / sponsor ID
- FOS / YFZXYDK20240115
- Conditions
- Fish Oils
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Study start
- 21 Jul 2024 (actual)
- Primary completion
- 21 Oct 2024 (actual)
- Study completion
- 2 Dec 2024 (actual)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no-treatment control group | No intervention | –No intervention measures are applied |
| fish oil supplement group | Experimental | Dietary Supplement: fish oilTwice a day, with one dose of DHA 300mg: EPA 60mg, for a continuous intervention of 90 days |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fish oilTwice a day, with one dose of DHA 300mg: EPA 60mg, for a continuous intervention of 90 days | Dietary supplement | fish oil supplement group |
Primary outcome
Axial length
Time frame: 15±2 days, 30±2 days, and 90±2 days
the change of axial length
1 secondary outcome
change in equivalent spherical
Time frame: 15±2 days, 30±2 days, and 90±2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fish oil in people with Fish Oils, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axial length (time frame: 15±2 days, 30±2 days, and 90±2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.