Efficacy and Safety of Astaxanthin in Volunteer With Refraction Errors

Not Applicable

• Conditions: Refractive Errors
• Interventions: Dietary Supplement: astaxanthin 6 mg; Dietary Supplement: Placebo; Dietary Supplement: astaxanthin 4 mg

• Registration Number: NCT05009810
• Lead Sponsor: Chulalongkorn University

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.

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-03
• Study First Submitted QC: 2021-08-10
• Last Update Submitted: 2021-08-10
• Study Start: 2021-08-15
• Study First Posted: 2021-08-18
• Last Update Posted: 2021-08-18
• Primary Completion: 2022-06-30
• Study Completion: 2022-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
astaxanthin 6 mg	astaxanthin 6 mg	The astaxanthin 6 mg will be taken 1 capsule once daily for 2 months.
Placebo	Placebo	The placebo will be taken 1 capsule once daily for 2 months.
astaxanthin 4 mg	astaxanthin 4 mg	The astaxanthin 4 mg will be taken 1 capsule once daily for 2 months.

Primary Outcome Measures

Name	Time	Method
Visual acuity value	2 months	Measured using Snellen Chart (logarithm of the minimal angle of resolution unit)

Secondary Outcome Measures

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