Efficacy and Safety of Astaxanthin in Volunteer With Refraction Errors

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy and Safety of Astaxanthin in Volunteer With Refraction Errors

Conditions
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Refractive Errors

Intervention / Treatment
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* Dietary Supplement: astaxanthin 4 mg
* Dietary Supplement: astaxanthin 6 mg
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-65 years Refraction errors, dry eye, or blurred vision Have a willingness to participate in the study Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: astaxanthin 4 mg<br>The astaxanthin 4 mg will be taken 1 capsule once daily for 2 months. | Dietary Supplement: astaxanthin 4 mg<br>* They will take astaxanthin 4 mg 1 capsule once daily for 2 months.<br>|
| Experimental: astaxanthin 6 mg<br>The astaxanthin 6 mg will be taken 1 capsule once daily for 2 months. | Dietary Supplement: astaxanthin 6 mg<br>* They will take astaxanthin 6 mg 1 capsule once daily for 2 months.<br>|
| Placebo Comparator: Placebo<br>The placebo will be taken 1 capsule once daily for 2 months. | Dietary Supplement: Placebo<br>* They will take placebo 1 capsule once daily for 2 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity value | Measured using Snellen Chart (logarithm of the minimal angle of resolution unit) | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Refractive status | Measured using Auto refractometer (two digit scale) | 2 months | 
| Eye fatigue status | Measured using eye fatigue questionnaire (scale 1 to 5 which are no symptom (1) to severe(5)) | 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)) | 2 months | 
| Skin erythema value | Measured using Mexameter (skin erythema index) | 2 months | 
| Skin melanin value | Measured using Mexameter (skin melanin index) | 2 months | 
| Skin humidity value | Measured using Corneometer (skin humidity index) | 2 months | 
| Skin transepidermal water loss value | Measured using Transepidermal water loss meter (skin transepidermal water loss index) | 2 months | 
| Aspartate transaminase value | Measured aspartate transaminase value (U/L) in blood | 2 months | 
| Alanine aminotransferase value | Measured alanine aminotransferase value (U/L) in blood | 2 months | 
| Alkaline phosphatase value | Measured alkaline phosphatase value (U/L) in blood | 2 months | 
| Blood urea nitrogen value | Measured blood urea nitrogen value (mg/dl) in blood | 2 months | 
| Creatinine value | Measured creatinine value (mg/dl) in blood | 2 months | 
| Adverse events | Measured using questionnaire (Yes or No) | 2 months |