Efficacy and Safety of Astaxanthin in Volunteer With Refraction Errors

Sponsor

Chulalongkorn University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05009810

Collaborator

(none)

180

Enrollment

Arms

11.5

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Refractive Errors	Dietary Supplement: astaxanthin 4 mg Dietary Supplement: astaxanthin 6 mg Dietary Supplement: Placebo	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Efficacy and Safety of Astaxanthin in Volunteer With Refraction Errors

Anticipated Study Start Date :

Aug 15, 2021

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jul 31, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Visual acuity value [2 months]
Measured using Snellen Chart (logarithm of the minimal angle of resolution unit)

Secondary Outcome Measures

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))
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)
Aspartate transaminase value [2 months]
Measured aspartate transaminase value (U/L) in blood
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Chulalongkorn University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pornanong Aramwit, Pharm.D., Ph.D, Professor, Chulalongkorn University

ClinicalTrials.gov Identifier:

NCT05009810

Other Study ID Numbers:

EC2103320

First Posted:

Aug 18, 2021

Last Update Posted:

Aug 18, 2021

Last Verified:

Aug 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Refractive Errors

Study Results

No Results Posted as of Aug 18, 2021