Effect of Omega-3 Fatty Acid Supplementation on Dry-AMD Progression

NCT ID: NCT05465252

Last Updated: 2026-01-02

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

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-17

Study Completion Date

2026-05-31

Brief Summary

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This randomized, double-blind, placebo-controlled study aims to evaluate the effect of krill oil supplementation in patients with dry age-related macular degeneration (AMD). Participants will receive 4 capsules of krill oil or placebo daily for a period of 3 months. Outcomes will be evaluated after 3-month treatment to assess differences between the two study groups.

Detailed Description

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Conditions

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Age-Related Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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olive oil

Group Type PLACEBO_COMPARATOR

Olive Oil

Intervention Type DIETARY_SUPPLEMENT

Qualified subjects start to take placebo from Day 1 in the trial. Specifically, subjects from placebo group take 4 capsules of olive oil, which has the same color and smell as the krill oil.

krill oil

Group Type EXPERIMENTAL

Krill Oil

Intervention Type DIETARY_SUPPLEMENT

Qualified subjects start to take supplementation from Day 1 in the trial. Specifically, subjects from Intervention group take 4 capsules of krill oil per day.

Interventions

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Krill Oil

Qualified subjects start to take supplementation from Day 1 in the trial. Specifically, subjects from Intervention group take 4 capsules of krill oil per day.

Intervention Type DIETARY_SUPPLEMENT

Olive Oil

Qualified subjects start to take placebo from Day 1 in the trial. Specifically, subjects from placebo group take 4 capsules of olive oil, which has the same color and smell as the krill oil.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Superba Boost

Eligibility Criteria

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Inclusion Criteria

* Adults diagnosed with dry AMD at an early or intermediate stage, classified according to the Beckman Classification and confirmed by fundus photography: (1) Early AMD: medium drusen (\>63 μm and ≤125 μm) without AMD-related pigmentary abnormalities; (2) Intermediate AMD: large drusen (\>125 μm), with or without AMD-related pigmentary abnormalities.
* Willing to stop supplementation of omega-3 fatty acids, choline, or astaxanthin.
* Willing to sign the informed consent, and willing to attend follow-up visits for at least 3 months.

Exclusion Criteria

* Any eye with disease that would interfere with the fundus examinations.
* Eye with choroidal neovascularization (CNV), geographic atrophy (GA), or high myopia.
* Surgeries that may interfere with AMD evaluation.
* Long-term use of any medications that are associated with retinal or neural toxicities.
* History of supplementation with lutein, zeaxanthin, DHA, or EPA, unless a wash-out period of at least 8 weeks is completed prior to enrollment.
* Intraocular pressure more than 26 mmHg.
* Received cataract surgery in 3 months.
* Other conditions: subjects with severe systemic diseases; any condition that causes high risk of drop-out, or low compliance, for instance cognition disorder; have been involved in other trial that interfere with the current visit plan; taking other angiogenesis Inhibitors drugs for treating cancer.
* Other conditions not suitable for the current study.
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Xiaodong Sun

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaodong Sun, PHD

Role: PRINCIPAL_INVESTIGATOR

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Locations

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Shanghai General Hospital, Shanghai Jiao Tong University

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Huixun Jia, PhD

Role: CONTACT

+86 18017317575

Jiayu Xu

Role: CONTACT

+86 18516200956

Facility Contacts

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Xiaodong Sun

Role: primary

+86-02163240090 ext. 6822

Other Identifiers

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SXD20220608

Identifier Type: -

Identifier Source: org_study_id

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