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Astaxanthin Effects on Osteoarthritis Associated Pain and Inflammatory Indicators (AXE OA PAIN)

Primary Purpose

Osteoarthritis, Knee

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
astaxanthin
Placebo
Sponsored by
Saint Luke's Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 years or older
  • Symptoms of knee pain
  • Radiographic evidence of mild to moderate arthritis
  • Able to provide written consent on their own behalf

Exclusion Criteria:

  • Pregnancy
  • Current tobacco use
  • Current substance abuse (alcohol or drug)
  • Presence of significant cardiovascular, pulmonary, hepatic, or renal disease
  • Prior history of knee trauma or surgery
  • Gout or pseudogout
  • Significant depression or anxiety scores on PHQ-9 and GAD-7, or pre-existing diagnosis of a significant mental health disorder
  • Presence of other chronic pain syndromes such as chronic low back or neck pain, fibromyalgia, or complex regional pain syndrome
  • Presence of systemic inflammatory conditions such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease
  • Symptomatic involvement of multiple other joints with osteoarthritis
  • Known allergy to fish or astaxanthin
  • BMI greater than 35
  • Participation in another clinical trial

Sites / Locations

  • Saint Luke's Hospital of Kansas City

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Astaxanthin

Placebo

Arm Description

Astaxanthin 12mg twice daily by mouth

Placebo twice daily by mouth

Outcomes

Primary Outcome Measures

Change in PROMIS Numeric Rating Pain Scale
Pain improvement in subjects is the primary outcome measure. The Patient Reported Outcomes Measurement Information Systems (PROMIS) Pain Intensity Scale 1a tool will be used. This scale ranges from 0-10, with 0 representing no pain and 10 representing the worst pain imaginable.

Secondary Outcome Measures

Change in PROMIS Pain interference score
Reduction in pain interference is a secondary outcome measure. The Patient Reported Outcomes Measurement Information Systems (PROMIS) Pain Interference Short Form 6b will be used as the survey tool for pain interference. This is a set of 6 questions to assess the degree to which pain has interfered with daily activities. There are 5 levels of pain interference from 0 (none at all) to 5 (very much or always). The higher the score, the greater the pain interference.
Change in PROMIS Physical function score
Improvement in physical function is a secondary outcome measure. The PROMIS Physical Function Short Form 6b will be used as the survey tool for physical limitation. There are 5 levels of limitation to physical function from 0 (without any difficulty) to 5 (unable to do). The higher the score, the greater the limitation
Change in Erythrocyte Sedimentation Rate
Change in ESR (mm/hr)
Change in C-reactive protein levels
Change in CRP levels (mg/L)
Change in Interleukin-6 levels
Change in IL-6 levels (pg/mL)
Change in Cartilage Oligomeric Matrix Protein levels
Change in COMP levels (ng/mL)

Full Information

First Posted
May 31, 2018
Last Updated
April 11, 2022
Sponsor
Saint Luke's Health System
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1. Study Identification

Unique Protocol Identification Number
NCT03664466
Brief Title
Astaxanthin Effects on Osteoarthritis Associated Pain and Inflammatory Indicators
Acronym
AXE OA PAIN
Official Title
Astaxanthin Effects on Osteoarthritis Associated Pain and Inflammatory Indicators
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Inadequate funding
Study Start Date
April 29, 2021 (Actual)
Primary Completion Date
January 25, 2022 (Actual)
Study Completion Date
January 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saint Luke's Health System

4. Oversight

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

5. Study Description

Brief Summary
This study is intended to assess the effects of astaxanthin use on pain, physical function, and inflammation as reflected by Patient-Reported Outcomes Measurement Information System (PROMIS) scores and levels of inflammatory biomarkers in subjects taking astaxanthin. If improvements in pain, function, and/or markers of inflammation could be demonstrated with the use of astaxanthin, this may suggest the potential for astaxanthin to be used in management of knee osteoarthritis (and possibly other forms of osteoarthritis) with less evident toxicity than seen with the presently available standard therapies (e.g. NSAIDS, opioids).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
double-blind
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Astaxanthin
Arm Type
Experimental
Arm Description
Astaxanthin 12mg twice daily by mouth
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo twice daily by mouth
Intervention Type
Dietary Supplement
Intervention Name(s)
astaxanthin
Intervention Description
astaxanthin capsules 12 mg twice daily
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
placebo capsules twice daily
Primary Outcome Measure Information:
Title
Change in PROMIS Numeric Rating Pain Scale
Description
Pain improvement in subjects is the primary outcome measure. The Patient Reported Outcomes Measurement Information Systems (PROMIS) Pain Intensity Scale 1a tool will be used. This scale ranges from 0-10, with 0 representing no pain and 10 representing the worst pain imaginable.
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Change in PROMIS Pain interference score
Description
Reduction in pain interference is a secondary outcome measure. The Patient Reported Outcomes Measurement Information Systems (PROMIS) Pain Interference Short Form 6b will be used as the survey tool for pain interference. This is a set of 6 questions to assess the degree to which pain has interfered with daily activities. There are 5 levels of pain interference from 0 (none at all) to 5 (very much or always). The higher the score, the greater the pain interference.
Time Frame
20 weeks
Title
Change in PROMIS Physical function score
Description
Improvement in physical function is a secondary outcome measure. The PROMIS Physical Function Short Form 6b will be used as the survey tool for physical limitation. There are 5 levels of limitation to physical function from 0 (without any difficulty) to 5 (unable to do). The higher the score, the greater the limitation
Time Frame
20 weeks
Title
Change in Erythrocyte Sedimentation Rate
Description
Change in ESR (mm/hr)
Time Frame
20 weeks
Title
Change in C-reactive protein levels
Description
Change in CRP levels (mg/L)
Time Frame
20 weeks
Title
Change in Interleukin-6 levels
Description
Change in IL-6 levels (pg/mL)
Time Frame
20 weeks
Title
Change in Cartilage Oligomeric Matrix Protein levels
Description
Change in COMP levels (ng/mL)
Time Frame
20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years or older Symptoms of knee pain Radiographic evidence of mild to moderate arthritis Able to provide written consent on their own behalf Exclusion Criteria: Pregnancy Current tobacco use Current substance abuse (alcohol or drug) Presence of significant cardiovascular, pulmonary, hepatic, or renal disease Prior history of knee trauma or surgery Gout or pseudogout Significant depression or anxiety scores on PHQ-9 and GAD-7, or pre-existing diagnosis of a significant mental health disorder Presence of other chronic pain syndromes such as chronic low back or neck pain, fibromyalgia, or complex regional pain syndrome Presence of systemic inflammatory conditions such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease Symptomatic involvement of multiple other joints with osteoarthritis Known allergy to fish or astaxanthin BMI greater than 35 Participation in another clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Elliott, MD
Organizational Affiliation
Saint Luke's Hospital of Kansas City
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Luke's Hospital of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Astaxanthin Effects on Osteoarthritis Associated Pain and Inflammatory Indicators

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