Refractive ErrorsNCT05009810
Efficacy and Safety of Astaxanthin in Volunteer With Refraction Errors
A study testing astaxanthin 4 mg and astaxanthin 6 mg in people with Refractive Errors, run by Chulalongkorn University.
Trial summary
This study will investigate efficacy and safety of astaxanthin in 180 volunteers with refraction errors. Visual test, skin test, liver function test, renal function test, and adverse event will be evaluated before and after taking astaxanthin for 1 and 2 months. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Refractive Errors
- What is being tested?
- astaxanthin 4 mg and astaxanthin 6 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2021to 31 Jul 2022
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- Refraction errors, dry eye, or blurred vision
- Have a willingness to participate in the study
Who cannot join
- Uncontrolled disease
- Have complications during the study
- Have astaxanthin more than 2 weeks
- Allergic to astaxanthin, seafood, or seaweed
- Osteoporosis or thyroid disease
- Immunodeficiency or taking immunosuppressants
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- Liver and kidney diseases
- A person with a brain disorder, vision or hearing unusual
- Pregnancy or lactation
- Cannot follow the protocol
- During participated in other studies
About this study
This study will investigate efficacy and safety of astaxanthin in 180 volunteers with refraction errors. Visual test, skin test, liver function test, renal function test, and adverse event will be evaluated before and after taking astaxanthin for 1 and 2 months.
Read the detailed description
This study will investigate efficacy and safety of astaxanthin in 180 volunteers with refraction errors. They will divided into 3 groups which are astaxanthin 4 mg group , astaxanthin 6 mg group, and placebo group. They will take the sample 1 capsule once daily for 2 months. Visual test, skin test, liver function test, renal function test, and adverse event will be evaluated before and after taking the sample for 1 and 2 months.
- Conditions
- Refractive Errors
- Being tested
- astaxanthin 4 mg, astaxanthin 6 mg, Placebo
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
astaxanthin 4 mgDietary supplement
They will take astaxanthin 4 mg 1 capsule once daily for 2 months.
astaxanthin 6 mgDietary supplement
They will take astaxanthin 6 mg 1 capsule once daily for 2 months.
PlaceboDietary supplement
They will take placebo 1 capsule once daily for 2 months.
| Study group | Role | What they receive |
|---|---|---|
| astaxanthin 4 mg | Experimental | The astaxanthin 4 mg will be taken 1 capsule once daily for 2 months. Receives: Dietary Supplement: astaxanthin 4 mg |
| astaxanthin 6 mg | Experimental | The astaxanthin 6 mg will be taken 1 capsule once daily for 2 months. Receives: Dietary Supplement: astaxanthin 6 mg |
| Placebo | Placebo comparator | The placebo will be taken 1 capsule once daily for 2 months. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity value
Measured using Snellen Chart (logarithm of the minimal angle of resolution unit)
Measured: 2 months
Secondary outcomes (13)
Refractive status
Measured using Auto refractometer (two digit scale)
Measured: 2 months
Eye fatigue status
Measured using eye fatigue questionnaire (scale 1 to 5 which are no symptom (1) to severe(5))
Measured: 2 months
Vision status
Measured using Thai National Eye Institute Visual Functioning Questionnaire 25 (scale 25 to 100 which are normal (25) to worse(100))
Measured: 2 months
Skin erythema value
Measured using Mexameter (skin erythema index)
Measured: 2 months
Skin melanin value
Measured using Mexameter (skin melanin index)
Measured: 2 months
Skin humidity value
Measured using Corneometer (skin humidity index)
Measured: 2 months
Skin transepidermal water loss value
Measured using Transepidermal water loss meter (skin transepidermal water loss index)
Measured: 2 months
Aspartate transaminase value
Measured aspartate transaminase value (U/L) in blood
Measured: 2 months
Alanine aminotransferase value
Measured alanine aminotransferase value (U/L) in blood
Measured: 2 months
Alkaline phosphatase value
Measured alkaline phosphatase value (U/L) in blood
Measured: 2 months
Blood urea nitrogen value
Measured blood urea nitrogen value (mg/dl) in blood
Measured: 2 months
Creatinine value
Measured creatinine value (mg/dl) in blood
Measured: 2 months
Adverse events
Measured using questionnaire (Yes or No)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start15 Aug 2021 (estimated)
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive ErrorsStudies of the same condition, open and under way.
- More trials run by Chulalongkorn 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05009810
- Sponsor's protocol ID
- EC2103320
- Status last verified
- Aug 2021
- First submitted
- 3 Aug 2021
- Last updated
- 18 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Astaxanthin in Volunteer With Refraction Errors
- ClinicalTrials.gov ID
- NCT05009810
- Acronym / sponsor ID
- EC2103320
- Conditions
- Refractive Errors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 15 Aug 2021 (estimated)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 18 Aug 2021 (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.
This study will investigate efficacy and safety of astaxanthin in 180 volunteers with refraction errors. Visual test, skin test, liver function test, renal function test, and adverse event will be evaluated before and after taking astaxanthin for 1 and 2 months.
Detailed description
This study will investigate efficacy and safety of astaxanthin in 180 volunteers with refraction errors. They will divided into 3 groups which are astaxanthin 4 mg group , astaxanthin 6 mg group, and placebo group. They will take the sample 1 capsule once daily for 2 months. Visual test, skin test, liver function test, renal function test, and adverse event will be evaluated before and after taking the sample for 1 and 2 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| astaxanthin 4 mg | Experimental | Dietary Supplement: astaxanthin 4 mgThe astaxanthin 4 mg will be taken 1 capsule once daily for 2 months. |
| astaxanthin 6 mg | Experimental | Dietary Supplement: astaxanthin 6 mgThe astaxanthin 6 mg will be taken 1 capsule once daily for 2 months. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe placebo will be taken 1 capsule once daily for 2 months. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65 years
- Refraction errors, dry eye, or blurred vision
- Have a willingness to participate in the study
Key exclusion criteria (11 listed)
- Uncontrolled disease
- Have complications during the study
- Have astaxanthin more than 2 weeks
- Allergic to astaxanthin, seafood, or seaweed
- Osteoporosis or thyroid disease
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 |
|---|---|---|
| astaxanthin 4 mgThey will take astaxanthin 4 mg 1 capsule once daily for 2 months. | Dietary supplement | astaxanthin 4 mg |
| astaxanthin 6 mgThey will take astaxanthin 6 mg 1 capsule once daily for 2 months. | Dietary supplement | astaxanthin 6 mg |
| PlaceboThey will take placebo 1 capsule once daily for 2 months. | Dietary supplement | Placebo |
Primary outcome
Visual acuity value
Time frame: 2 months
Measured using Snellen Chart (logarithm of the minimal angle of resolution unit)
13 secondary outcomes
Refractive status
Time frame: 2 months
Eye fatigue status
Time frame: 2 months
Vision status
Time frame: 2 months
Skin erythema value
Time frame: 2 months
Skin melanin value
Time frame: 2 months
Skin humidity value
Time frame: 2 months
Skin transepidermal water loss value
Time frame: 2 months
Aspartate transaminase value
Time frame: 2 months
Alanine aminotransferase value
Time frame: 2 months
Alkaline phosphatase value
Time frame: 2 months
Blood urea nitrogen value
Time frame: 2 months
Creatinine value
Time frame: 2 months
Adverse events
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing astaxanthin 4 mg and astaxanthin 6 mg in people with Refractive Errors, run by Chulalongkorn 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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 18 Aug 2021. 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?
Results are not available in the source record.
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?
Visual acuity value (time frame: 2 months). 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 18 Aug 2021.