Efficacy and Safety of Astaxanthin in Volunteer With Refraction Errors

NCT05009810 | Unknown

• 1 other identifier: EC2103320
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Refractive Errors

Outcome Measures

Primary Outcomes (1)

• Visual acuity value

  Measured using Snellen Chart (logarithm of the minimal angle of resolution unit)

  2 months

Secondary Outcomes (13)

• Refractive status

  2 months

• Eye fatigue status

  2 months

• Vision status

  2 months

• Skin erythema value

  2 months

• Skin melanin value

  2 months

Study Arms (3)

astaxanthin 4 mg

EXPERIMENTAL

The astaxanthin 4 mg will be taken 1 capsule once daily for 2 months.

Dietary Supplement: astaxanthin 4 mg

astaxanthin 6 mg

EXPERIMENTAL

The astaxanthin 6 mg will be taken 1 capsule once daily for 2 months.

Dietary Supplement: astaxanthin 6 mg

Placebo

PLACEBO COMPARATOR

The placebo will be taken 1 capsule once daily for 2 months.

Dietary Supplement: Placebo

Interventions

astaxanthin 4 mg DIETARY_SUPPLEMENT

They will take astaxanthin 4 mg 1 capsule once daily for 2 months.

astaxanthin 4 mg

astaxanthin 6 mg DIETARY_SUPPLEMENT

They will take astaxanthin 6 mg 1 capsule once daily for 2 months.

astaxanthin 6 mg

Placebo DIETARY_SUPPLEMENT

They will take placebo 1 capsule once daily for 2 months.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years
• Refraction errors, dry eye, or blurred vision
• Have a willingness to participate in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead

MeSH Terms

Conditions

Refractive Errors

Interventions

astaxanthine

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 18, 2021
• Study Start: August 15, 2021
• Primary Completion: June 30, 2022
• Study Completion: July 31, 2022
• Last Updated: August 18, 2021

Record last verified: 2021-08