Efficacy and Safety of Astaxanthin in Volunteer With Refraction Errors

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Refractive Errors
• Intervention / Treatment: Dietary supplement: astaxanthin 4 mg; Dietary supplement: astaxanthin 6 mg; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: astaxanthin 4 mg; The astaxanthin 4 mg will be taken 1 capsule once daily for 2 months.	Dietary supplement: astaxanthin 4 mg; They will take astaxanthin 4 mg 1 capsule once daily for 2 months.
Experimental: astaxanthin 6 mg; The astaxanthin 6 mg will be taken 1 capsule once daily for 2 months.	Dietary supplement: astaxanthin 6 mg; They will take astaxanthin 6 mg 1 capsule once daily for 2 months.
Placebo Comparator: Placebo; The placebo will be taken 1 capsule once daily for 2 months.	Dietary supplement: Placebo; They will take placebo 1 capsule once daily for 2 months.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chulalongkorn University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 15, 2021
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): July 31, 2022

Study Registration Dates

• First Submitted: August 3, 2021
• First Submitted That Met QC Criteria: August 10, 2021
• First Posted (Actual): August 18, 2021

Study Record Updates

• Last Update Posted (Actual): August 18, 2021
• Last Update Submitted That Met QC Criteria: August 10, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: EC2103320

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No