Vision DisordersNCT06098677
Effect of Carotenoids Supplementation on Visual Function in Chinese Subjects
A study testing Carotenoids supplementation in people with Vision Disorders, run by Zhongshan Ophthalmic Center, Sun Yat-sen University.
Trial summary
The macula is a pigmented area at the center of the retina, and responsible for the central, high-resolution color vision. Age-related macular degeneration (AMD) is a disease of the macula and is the leading cause of irreversible vision impairment and blindness worldwide. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vision Disorders
- What is being tested?
- Carotenoids supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chinese subjects
- Age 35 years or above
- Monocular BCVA of 6/6 or better
- No more than +/- 5 diopters spherical equivalence of refraction
- No previous consumption of supplements containing macular carotenoids (L, Z and/or MZ) within the last 12 months
- Without severe retinal diseases (eg. retinal detachment, glaucoma, macular hole, idiopathic epiretinal membrane, retinitis pigmentosa, and age-related macular degeneration (assessed by experienced ophthalmologists during ocular examination)
Who cannot join
- Unable to provide informed consent
- With diagnosed diabetes
- With severe systemic disease which affects physical mobility and successful follow-up
- Contrast sensitivity at a spatial density of 6 cpd ≤ 1.5 % at baseline in the eye with better visual acuity
- Subjects who plan to receive cataract surgery within the next year
- Subjects who are unable to cooperate with the examinations during follow-ups, such as those who suffer from other serious systemic diseases or mental abnormalities
- History of intraocular surgery (eg. cataract surgery, vitrectomy and retinal laser photocoagulation)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Carotenoids Supplementation on Visual Function in Chinese Subjects Free of Retinal Disease: A Randomized Clinical Trial
The macula is a pigmented area at the center of the retina, and responsible for the central, high-resolution color vision. Age-related macular degeneration (AMD) is a disease of the macula and is the leading cause of irreversible vision impairment and blindness worldwide. The yellow pigment at the macula is referred to as macular pigment. There is now strong evidence showing that macular pigment (MP), which is composed of the dietary carotenoids lutein (L), meso-zeaxanthin (MZ), and zeaxanthin (Z) is protective against AMD and vision loss. MP is a powerful antioxidant and also filters short-wavelength (blue) light at the macula. The AREDS2 study concluded that supplementation of L and Z is beneficial for patients with non-advanced age-related macular degeneration (AMD). The CREST and other studies had reported that dietary supplementation of these carotenoids could enhance contrast sensitivity among the Caucasian population, whereas little information is known about the effect of dietary supplementation of carotenoids on contrast sensitivity among Chinese. Thus in this study, we aim to investigate whether supplementation of a formulation containing 10 mg L, 10 mg MZ, and 2mg Z on contrast sensitivity in Chinese subjects free of retinal disease. This study is a single-center, double-blinded, placebo-controlled, randomized clinical trial conducted at Zhongshan Ophthalmic Center (ZOC), Sun Yat-sen University, Guangzhou, China. Participants in the intervention group received oral supplementation of 10 mg L, 10 mg MZ, and 2mg Z in a formula base oil suspension as one soft gel capsule in the morning per day. Participants in the control group receive one soft gel capsule of placebo oil per day. The intervention and placebo supplements are identical in external appearance, and the two treatments are therefore indistinguishable from each other. The duration of the study intervention is 12 months, and study visits are conducted at baseline, 3 months, 6 months, and 12 months. The primary outcome measure is the change in contrast sensitivity (CS) at 6 cycles per degree (cpd) over the study course: Y=CS4-CS1, where CS1 is CS at 6 cpd at baseline, CS4 is the CS at 6cpd at the 12-month follow-up. The secondary outcomes of this study include CS at other cpds and at other study visits, best-corrected visual acuity, subjective visual function, and skin carotenoid levels at each study visit.
- Conditions
- Vision Disorders
- Being tested
- Carotenoids supplementation, Placebo
- Medical subject headings
- Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotenoids supplementationDietary supplement
Daily oral supplementation of a soft gel capsule containing 10mg lutein (L), 10mg meso-zeaxanthin (MZ) and 2mg zeaxanthin (Z).
PlaceboDietary supplement
Daily oral supplementation of a soft gel capsule containing only placebo oil
| Study group | Role | What they receive |
|---|---|---|
| Carotenoids group | Experimental | Participants in the intervention group receive oral supplementation of 10 mg L, 10 mg MZ and 2mg Z in a formula base oil suspension as one soft gel capsule in the morning per day. Each capsule contains 22 mg of carotenoids (10+10+2mg), thus each participant in the intervention group will receive a total of 22 mg of carotenoids per day. Receives: Dietary Supplement: Carotenoids supplementation |
| Placebo group | Placebo comparator | Participants in the control group receive one soft gel capsule of placebo oil per day. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in contrast sensitivity (CS) at 6 cycles per degree (cpd) over 1 year
CS at 6 cpd at the 12-month follow-up minus CS at 6 cpd at baseline.
Measured: 1 year
Secondary outcomes (4)
CS at other cpds and at other study visits
CS at 1.2, 2.4, 9.6 and 15.15 cpd at baseline, 3-month follow-up, 6-month follow-up and 12-month follow-up; as well as CS at 6 cpd at 3-month follow-up and 6-month follow-up
Measured: 1 year
Best-corrected visual acuity
Best-corrected visual acuity at baseline, 3-month follow-up, 6-month follow-up and 12-month follow-up
Measured: 1 year
Subjective visual function
Subjective visual function measured by questionnaire at baseline, 3-month follow-up, 6-month follow-up and 12-month follow-up
Measured: 1 year
Skin carotenoids score
Skin carotenoids score at baseline, 3-month follow-up, 6-month follow-up and 12-month follow-up
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start1 May 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vision DisordersStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Blackmores (China) CO., Ltd
- Responsible party
- Principal investigator, Xiaotong Han, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06098677
- Sponsor's protocol ID
- 2022KYPJ141
- Status last verified
- Jan 2026
- First submitted
- 19 Oct 2023
- Last updated
- 23 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xu K, Tang X, Zhang Y, Tay JP, Zhang S, Qin Y, Wong W, He M, Han X. Effect of carotenoids supplementation on visual function in Chinese adults free of retinal disease: protocol for the CSV double-blind, randomised, placebo-controlled trial. BMJ Open. 2026 Mar 26;16(3):e112364. doi: 10.1136/bmjopen-2025-112364.
PubMed 41887628
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Carotenoids Supplementation on Visual Function in Chinese Subjects Free of Retinal Disease: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06098677
- Acronym / sponsor ID
- 2022KYPJ141
- Conditions
- Vision Disorders
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Blackmores (China) CO., Ltd
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Oct 2023 (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 macula is a pigmented area at the center of the retina, and responsible for the central, high-resolution color vision. Age-related macular degeneration (AMD) is a disease of the macula and is the leading cause of irreversible vision impairment and blindness worldwide. The yellow pigment at the macula is referred to as macular pigment. There is now strong evidence showing that macular pigment (MP), which is composed of the dietary carotenoids lutein (L), meso-zeaxanthin (MZ), and zeaxanthin (Z) is protective against AMD and vision loss. MP is a powerful antioxidant and also filters short-wavelength (blue) light at the macula. The AREDS2 study concluded that supplementation of L and Z is beneficial for patients with non-advanced age-related macular degeneration (AMD). The CREST and other studies had reported that dietary supplementation of these carotenoids could enhance contrast sensitivity among the Caucasian population, whereas little information is known about the effect of dietary supplementation of carotenoids on contrast sensitivity among Chinese. Thus in this study, we aim to investigate whether supplementation of a formulation containing 10 mg L, 10 mg MZ, and 2mg Z on contrast sensitivity in Chinese subjects free of retinal disease. This study is a single-center, double-blinded, placebo-controlled, randomized clinical trial conducted at Zhongshan Ophthalmic Center (ZOC), Sun Yat-sen University, Guangzhou, China. Participants in the intervention group received oral supplementation of 10 mg L, 10 mg MZ, and 2mg Z in a formula base oil suspension as one soft gel capsule in the morning per day. Participants in the control group receive one soft gel capsule of placebo oil per day. The intervention and placebo supplements are identical in external appearance, and the two treatments are therefore indistinguishable from each other. The duration of the study intervention is 12 months, and study visits are conducted at baseline, 3 months, 6 months, and 12 months. The primary outcome measure is the change in contrast sensitivity (CS) at 6 cycles per degree (cpd) over the study course: Y=CS4-CS1, where CS1 is CS at 6 cpd at baseline, CS4 is the CS at 6cpd at the 12-month follow-up. The secondary outcomes of this study include CS at other cpds and at other study visits, best-corrected visual acuity, subjective visual function, and skin carotenoid levels at each study visit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carotenoids group | Experimental | Dietary Supplement: Carotenoids supplementationParticipants in the intervention group receive oral supplementation of 10 mg L, 10 mg MZ and 2mg Z in a formula base oil suspension as one soft gel capsule in the morning per day. Each capsule contains 22 mg of carotenoids (10+10+2mg), thus each participant in the intervention group will receive a total of 22 mg of carotenoids per day. |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboParticipants in the control group receive one soft gel capsule of placebo oil per day. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Chinese subjects
- Age 35 years or above
- Monocular BCVA of 6/6 or better
- No more than +/- 5 diopters spherical equivalence of refraction
- No previous consumption of supplements containing macular carotenoids (L, Z and/or MZ) within the last 12 months
Key exclusion criteria (7 listed)
- Unable to provide informed consent
- With diagnosed diabetes
- With severe systemic disease which affects physical mobility and successful follow-up
- Contrast sensitivity at a spatial density of 6 cpd ≤ 1.5 % at baseline in the eye with better visual acuity
- Subjects who plan to receive cataract surgery within the next year
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 |
|---|---|---|
| Carotenoids supplementationDaily oral supplementation of a soft gel capsule containing 10mg lutein (L), 10mg meso-zeaxanthin (MZ) and 2mg zeaxanthin (Z). | Dietary supplement | Carotenoids group |
| PlaceboDaily oral supplementation of a soft gel capsule containing only placebo oil | Dietary supplement | Placebo group |
Primary outcome
Change in contrast sensitivity (CS) at 6 cycles per degree (cpd) over 1 year
Time frame: 1 year
CS at 6 cpd at the 12-month follow-up minus CS at 6 cpd at baseline.
4 secondary outcomes
CS at other cpds and at other study visits
Time frame: 1 year
Best-corrected visual acuity
Time frame: 1 year
Subjective visual function
Time frame: 1 year
Skin carotenoids score
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Derived from this study: PubMed 41887628Xu K, Tang X, Zhang Y, Tay JP, Zhang S, Qin Y, Wong W, He M, Han X. Effect of carotenoids supplementation on visual function in Chinese adults free of retinal disease: protocol for the CSV double-blind, randomised, placebo-controlled trial. BMJ Open. 2026 Mar 26;16(3):e112364. doi: 10.1136/bmjopen-2025-112364.
- Individual participant dataSharing planned: No
Related trials for Vision Disorders
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
RecruitingObservational study
DICER1-related Pleuropulmonary Blastoma Cancer Predisposition Syndrome: A Natural History Study
Pleuropulmonary Blastoma, Cystic Nephroma
Enrolling by invitationPhase 2
The Progressive Supranuclear Palsy Clinical Trial Platform - Regimen B: LM11A-31
PSP - Progressive Supranuclear Palsy
RecruitingPhase 3
A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
Insomia Disorder
RecruitingPhase 1/2
Tributyrin for Progressive Supranuclear Palsy (PSP): Virtual Trial
Parkinson Disease, Multiple System Atrophy
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.
Questions about this trial
What is this clinical trial studying?
A study testing Carotenoids supplementation in people with Vision Disorders, run by Zhongshan Ophthalmic Center, Sun Yat-sen University.
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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaotong Han, PhD (81-020-6660-4125, hanxiaotong2@gzzoc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in contrast sensitivity (CS) at 6 cycles per degree (cpd) over 1 year (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06098677, which also lists 1 linked publication.
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 23 Jan 2026.