Astaxanthin Effects on Osteoarthritis Associated Pain and Inflammatory Indicators

Osteoarthritis, Knee Clinical Trial

— AXE OA PAIN  

Official title:

Astaxanthin Effects on Osteoarthritis Associated Pain and Inflammatory Indicators

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03664466
• Other study ID #: AXE OA PAIN
• Status: Withdrawn
• Phase: N/A
• Start date: April 29, 2021
• Est. completion date: January 25, 2022

Study information

• Verified date: April 2022
• Source: Saint Luke's Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 25, 2022
• Est. primary completion date: January 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Dietary Supplement:
• astaxanthin
astaxanthin capsules 12 mg twice daily

Other:
• Placebo
placebo capsules twice daily

Locations

Country	Name	City	State
United States	Saint Luke's Hospital of Kansas City	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Saint Luke's Health System

Country where clinical trial is conducted

United States, 

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* Note: There are 54 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	20 weeks
Secondary	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.	20 weeks
Secondary	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	20 weeks
Secondary	Change in Erythrocyte Sedimentation Rate	Change in ESR (mm/hr)	20 weeks
Secondary	Change in C-reactive protein levels	Change in CRP levels (mg/L)	20 weeks
Secondary	Change in Interleukin-6 levels	Change in IL-6 levels (pg/mL)	20 weeks
Secondary	Change in Cartilage Oligomeric Matrix Protein levels	Change in COMP levels (ng/mL)	20 weeks