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

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ClinicalTrials.gov Identifier: NCT03664466
Recruitment Status : Not yet recruiting
First Posted : September 10, 2018
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Saint Luke's Health System

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).

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Dietary Supplement: astaxanthin Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: double-blind
Primary Purpose: Treatment
Official Title: Astaxanthin Effects on Osteoarthritis Associated Pain and Inflammatory Indicators
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Astaxanthin

Arm Intervention/treatment
Experimental: Astaxanthin
Astaxanthin 12mg twice daily by mouth
Dietary Supplement: astaxanthin
astaxanthin capsules 12 mg twice daily

Placebo Comparator: Placebo
Placebo twice daily by mouth
Other: Placebo
placebo capsules twice daily




Primary Outcome Measures :
  1. Change in PROMIS Numeric Rating Pain Scale [ Time Frame: 20 weeks ]
    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 :
  1. Change in PROMIS Pain interference score [ Time Frame: 20 weeks ]
    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.

  2. Change in PROMIS Physical function score [ Time Frame: 20 weeks ]
    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

  3. Change in Erythrocyte Sedimentation Rate [ Time Frame: 20 weeks ]
    Change in ESR (mm/hr)

  4. Change in C-reactive protein levels [ Time Frame: 20 weeks ]
    Change in CRP levels (mg/L)

  5. Change in Interleukin-6 levels [ Time Frame: 20 weeks ]
    Change in IL-6 levels (pg/mL)

  6. Change in Cartilage Oligomeric Matrix Protein levels [ Time Frame: 20 weeks ]
    Change in COMP levels (ng/mL)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664466


Contacts
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Contact: Jennifer Elliott, MD 816-932-2932 jelliott@saintlukeskc.org
Contact: Aaron Heller, DO 317-796-6393 helleran@umkc.edu

Sponsors and Collaborators
Saint Luke's Health System
Investigators
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Principal Investigator: Jennifer Elliott, MD Saint Luke's Hospital of Kansas City

Publications:
CDC. Multiple cause of death data on CDC WONDER. Atlanta, GA: US Department of Health and Human Services, CDC; 2016. http://wonder.cdc.gov/mcd.html
Astaxanthin as a pigmenter in salmon feed. Chemicals HVF. Hoffman-La Roche Inc., 1987.
Iwabayashi M et al., Efficacy and safety of eight-week treatment with astaxanthin in individuals screened for increased oxidative stress burden. Anti-aging medicine. 2009;6(4):15-21.
Kim KY et al., The effects of astaxanthin supplements on lipid peroxidation and antioxidant status in postmenopausal women. Nutritional Sciences. 2004;7(1):41-46.
Singh S, Shahi NT, Shahi U, Kumar D. Serum Cartilage Oligomeric Matrix Protein (COMP) Estimation: A Tool to Assess Efficacy of Treatment in Knee Osteoarthritis. MOJ Orthopedics & Rheumatology 2014; 1(3): 00017.

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Responsible Party: Saint Luke's Health System
ClinicalTrials.gov Identifier: NCT03664466     History of Changes
Other Study ID Numbers: AXE OA PAIN
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases