Efficacy and Safety of Astaxanthin in Volunteer With Refraction Errors

Refractive Errors Clinical Trial

Official title:

Efficacy and Safety of Astaxanthin in Volunteer With Refraction Errors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05009810
• Other study ID #: EC2103320
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 15, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: August 2021
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: July 31, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Refractive Errors

Intervention

Dietary Supplement:
• astaxanthin 4 mg
They will take astaxanthin 4 mg 1 capsule once daily for 2 months.
• astaxanthin 6 mg
They will take astaxanthin 6 mg 1 capsule once daily for 2 months.
• Placebo
They will take placebo 1 capsule once daily for 2 months.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity value	Measured using Snellen Chart (logarithm of the minimal angle of resolution unit)	2 months
Secondary	Refractive status	Measured using Auto refractometer (two digit scale)	2 months
Secondary	Eye fatigue status	Measured using eye fatigue questionnaire (scale 1 to 5 which are no symptom (1) to severe(5))	2 months
Secondary	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
Secondary	Skin erythema value	Measured using Mexameter (skin erythema index)	2 months
Secondary	Skin melanin value	Measured using Mexameter (skin melanin index)	2 months
Secondary	Skin humidity value	Measured using Corneometer (skin humidity index)	2 months
Secondary	Skin transepidermal water loss value	Measured using Transepidermal water loss meter (skin transepidermal water loss index)	2 months
Secondary	Aspartate transaminase value	Measured aspartate transaminase value (U/L) in blood	2 months
Secondary	Alanine aminotransferase value	Measured alanine aminotransferase value (U/L) in blood	2 months
Secondary	Alkaline phosphatase value	Measured alkaline phosphatase value (U/L) in blood	2 months
Secondary	Blood urea nitrogen value	Measured blood urea nitrogen value (mg/dl) in blood	2 months
Secondary	Creatinine value	Measured creatinine value (mg/dl) in blood	2 months
Secondary	Adverse events	Measured using questionnaire (Yes or No)	2 months