Refractive Errors
Conditions
Brief 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.
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.
Interventions
DIETARY_SUPPLEMENTastaxanthin 4 mg
They will take astaxanthin 4 mg 1 capsule once daily for 2 months.
DIETARY_SUPPLEMENTastaxanthin 6 mg
They will take astaxanthin 6 mg 1 capsule once daily for 2 months.
DIETARY_SUPPLEMENTPlacebo
They will take placebo 1 capsule once daily for 2 months.
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual acuity value | 2 months | Measured using Snellen Chart (logarithm of the minimal angle of resolution unit) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eye fatigue status | 2 months | Measured using eye fatigue questionnaire (scale 1 to 5 which are no symptom (1) to severe(5)) |
| Vision status | 2 months | Measured using Thai National Eye Institute Visual Functioning Questionnaire 25 (scale 25 to 100 which are normal (25) to worse(100)) |
| Skin erythema value | 2 months | Measured using Mexameter (skin erythema index) |
| Skin melanin value | 2 months | Measured using Mexameter (skin melanin index) |
| Skin humidity value | 2 months | Measured using Corneometer (skin humidity index) |
| Skin transepidermal water loss value | 2 months | Measured using Transepidermal water loss meter (skin transepidermal water loss index) |
| Refractive status | 2 months | Measured using Auto refractometer (two digit scale) |
| Alanine aminotransferase value | 2 months | Measured alanine aminotransferase value (U/L) in blood |
| Alkaline phosphatase value | 2 months | Measured alkaline phosphatase value (U/L) in blood |
| Blood urea nitrogen value | 2 months | Measured blood urea nitrogen value (mg/dl) in blood |
| Creatinine value | 2 months | Measured creatinine value (mg/dl) in blood |
| Adverse events | 2 months | Measured using questionnaire (Yes or No) |
| Aspartate transaminase value | 2 months | Measured aspartate transaminase value (U/L) in blood |
Outcome results
None listed