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Efficacy and Safety of Astaxanthin in Volunteer With Refraction Errors

Primary Purpose

Refractive Errors

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
astaxanthin 4 mg
astaxanthin 6 mg
Placebo
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Refractive Errors

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    astaxanthin 4 mg

    astaxanthin 6 mg

    Placebo

    Arm Description

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

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

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Refractive status
    Measured using Auto refractometer (two digit scale)
    Eye fatigue status
    Measured using eye fatigue questionnaire (scale 1 to 5 which are no symptom (1) to severe(5))
    Vision status
    Measured using Thai National Eye Institute Visual Functioning Questionnaire 25 (scale 25 to 100 which are normal (25) to worse(100))
    Skin erythema value
    Measured using Mexameter (skin erythema index)
    Skin melanin value
    Measured using Mexameter (skin melanin index)
    Skin humidity value
    Measured using Corneometer (skin humidity index)
    Skin transepidermal water loss value
    Measured using Transepidermal water loss meter (skin transepidermal water loss index)
    Aspartate transaminase value
    Measured aspartate transaminase value (U/L) in blood
    Alanine aminotransferase value
    Measured alanine aminotransferase value (U/L) in blood
    Alkaline phosphatase value
    Measured alkaline phosphatase value (U/L) in blood
    Blood urea nitrogen value
    Measured blood urea nitrogen value (mg/dl) in blood
    Creatinine value
    Measured creatinine value (mg/dl) in blood
    Adverse events
    Measured using questionnaire (Yes or No)

    Full Information

    First Posted
    August 3, 2021
    Last Updated
    August 10, 2021
    Sponsor
    Chulalongkorn University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05009810
    Brief Title
    Efficacy and Safety of Astaxanthin in Volunteer With Refraction Errors
    Official Title
    Efficacy and Safety of Astaxanthin in Volunteer With Refraction Errors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 15, 2021 (Anticipated)
    Primary Completion Date
    June 30, 2022 (Anticipated)
    Study Completion Date
    July 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chulalongkorn University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Refractive Errors

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    180 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    astaxanthin 4 mg
    Arm Type
    Experimental
    Arm Description
    The astaxanthin 4 mg will be taken 1 capsule once daily for 2 months.
    Arm Title
    astaxanthin 6 mg
    Arm Type
    Experimental
    Arm Description
    The astaxanthin 6 mg will be taken 1 capsule once daily for 2 months.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    The placebo will be taken 1 capsule once daily for 2 months.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    astaxanthin 4 mg
    Intervention Description
    They will take astaxanthin 4 mg 1 capsule once daily for 2 months.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    astaxanthin 6 mg
    Intervention Description
    They will take astaxanthin 6 mg 1 capsule once daily for 2 months.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Intervention Description
    They will take placebo 1 capsule once daily for 2 months.
    Primary Outcome Measure Information:
    Title
    Visual acuity value
    Description
    Measured using Snellen Chart (logarithm of the minimal angle of resolution unit)
    Time Frame
    2 months
    Secondary Outcome Measure Information:
    Title
    Refractive status
    Description
    Measured using Auto refractometer (two digit scale)
    Time Frame
    2 months
    Title
    Eye fatigue status
    Description
    Measured using eye fatigue questionnaire (scale 1 to 5 which are no symptom (1) to severe(5))
    Time Frame
    2 months
    Title
    Vision status
    Description
    Measured using Thai National Eye Institute Visual Functioning Questionnaire 25 (scale 25 to 100 which are normal (25) to worse(100))
    Time Frame
    2 months
    Title
    Skin erythema value
    Description
    Measured using Mexameter (skin erythema index)
    Time Frame
    2 months
    Title
    Skin melanin value
    Description
    Measured using Mexameter (skin melanin index)
    Time Frame
    2 months
    Title
    Skin humidity value
    Description
    Measured using Corneometer (skin humidity index)
    Time Frame
    2 months
    Title
    Skin transepidermal water loss value
    Description
    Measured using Transepidermal water loss meter (skin transepidermal water loss index)
    Time Frame
    2 months
    Title
    Aspartate transaminase value
    Description
    Measured aspartate transaminase value (U/L) in blood
    Time Frame
    2 months
    Title
    Alanine aminotransferase value
    Description
    Measured alanine aminotransferase value (U/L) in blood
    Time Frame
    2 months
    Title
    Alkaline phosphatase value
    Description
    Measured alkaline phosphatase value (U/L) in blood
    Time Frame
    2 months
    Title
    Blood urea nitrogen value
    Description
    Measured blood urea nitrogen value (mg/dl) in blood
    Time Frame
    2 months
    Title
    Creatinine value
    Description
    Measured creatinine value (mg/dl) in blood
    Time Frame
    2 months
    Title
    Adverse events
    Description
    Measured using questionnaire (Yes or No)
    Time Frame
    2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

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    Efficacy and Safety of Astaxanthin in Volunteer With Refraction Errors

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