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Osteoarthritis, KneeAXE OA PAINNCT03664466

Astaxanthin Effects on Osteoarthritis Associated Pain and Inflammatory Indicators

A study testing astaxanthin in people with Osteoarthritis, Knee, run by Saint Luke's Health System at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
astaxanthin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
29 Apr 2021to 25 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

Other trials in United States

About this study

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).

Being tested
astaxanthin, Placebo
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • astaxanthinDietary supplement

    astaxanthin capsules 12 mg twice daily

  • PlaceboOther

    placebo capsules twice daily

Study groups in NCT03664466
Study groupRoleWhat they receive
AstaxanthinExperimentalAstaxanthin 12mg twice daily by mouth
Receives: Dietary Supplement: astaxanthin
PlaceboPlacebo comparatorPlacebo twice daily by mouth
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 20 weeks

Secondary outcomes (6)

  1. 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.

    Measured: 20 weeks

  2. 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

    Measured: 20 weeks

  3. Change in Erythrocyte Sedimentation Rate

    Change in ESR (mm/hr)

    Measured: 20 weeks

  4. Change in C-reactive protein levels

    Change in CRP levels (mg/L)

    Measured: 20 weeks

  5. Change in Interleukin-6 levels

    Change in IL-6 levels (pg/mL)

    Measured: 20 weeks

  6. Change in Cartilage Oligomeric Matrix Protein levels

    Change in COMP levels (ng/mL)

    Measured: 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2018
  2. Study start29 Apr 2021
  3. Primary completion25 Jan 2022
  4. Study completion25 Jan 2022

Why it stopped: Inadequate funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03664466
Sponsor's protocol ID
AXE OA PAIN
Acronym
AXE OA PAIN
Status last verified
Apr 2022
First submitted
31 May 2018
Last updated
19 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum. 1986 Aug;29(8):1039-49. doi: 10.1002/art.1780290816.

    PubMed 3741515

  • Sokolove J, Lepus CM. Role of inflammation in the pathogenesis of osteoarthritis: latest findings and interpretations. Ther Adv Musculoskelet Dis. 2013 Apr;5(2):77-94. doi: 10.1177/1759720X12467868.

    PubMed 23641259

  • Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, Bridgett L, Williams S, Guillemin F, Hill CL, Laslett LL, Jones G, Cicuttini F, Osborne R, Vos T, Buchbinder R, Woolf A, March L. The global burden of hip and knee osteoarthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1323-30. doi: 10.1136/annrheumdis-2013-204763. Epub 2014 Feb 19.

    PubMed 24553908

  • Centers for Disease Control and Prevention (CDC). Prevalence and most common causes of disability among adults--United States, 2005. MMWR Morb Mortal Wkly Rep. 2009 May 1;58(16):421-6.

    PubMed 19407734

  • Murphy L, Helmick CG. The impact of osteoarthritis in the United States: a population-health perspective. Am J Nurs. 2012 Mar;112(3 Suppl 1):S13-9. doi: 10.1097/01.NAJ.0000412646.80054.21.

    PubMed 22373741

  • Centers for Disease Control and Prevention (CDC). National and state medical expenditures and lost earnings attributable to arthritis and other rheumatic conditions--United States, 2003. MMWR Morb Mortal Wkly Rep. 2007 Jan 12;56(1):4-7.

    PubMed 17218935

  • Hochberg MC. Mortality in osteoarthritis. Clin Exp Rheumatol. 2008 Sep-Oct;26(5 Suppl 51):S120-4.

    PubMed 19026154

  • Coxib and traditional NSAID Trialists' (CNT) Collaboration; Bhala N, Emberson J, Merhi A, Abramson S, Arber N, Baron JA, Bombardier C, Cannon C, Farkouh ME, FitzGerald GA, Goss P, Halls H, Hawk E, Hawkey C, Hennekens C, Hochberg M, Holland LE, Kearney PM, Laine L, Lanas A, Lance P, Laupacis A, Oates J, Patrono C, Schnitzer TJ, Solomon S, Tugwell P, Wilson K, Wittes J, Baigent C. Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials. Lancet. 2013 Aug 31;382(9894):769-79. doi: 10.1016/S0140-6736(13)60900-9. Epub 2013 May 30.

    PubMed 23726390

  • National Center for Health Statistics (US). Health, United States, 2014: With Special Feature on Adults Aged 55-64. Hyattsville (MD): National Center for Health Statistics (US); 2015 May. Report No.: 2015-1232. Available from http://www.ncbi.nlm.nih.gov/books/NBK299348/

    PubMed 26086064

  • 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

  • Centers for Disease Control and Prevention (CDC). Vital signs: overdoses of prescription opioid pain relievers---United States, 1999--2008. MMWR Morb Mortal Wkly Rep. 2011 Nov 4;60(43):1487-92.

    PubMed 22048730

  • Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain - United States, 2016. MMWR Recomm Rep. 2016 Mar 18;65(1):1-49. doi: 10.15585/mmwr.rr6501e1.

    PubMed 26987082

  • Le Graverand-Gastineau MP. Disease modifying osteoarthritis drugs: facing development challenges and choosing molecular targets. Curr Drug Targets. 2010 May;11(5):528-35. doi: 10.2174/138945010791011893.

    PubMed 20199396

  • Astaxanthin as a pigmenter in salmon feed. Chemicals HVF. Hoffman-La Roche Inc., 1987.

  • Higuera-Ciapara I, Felix-Valenzuela L, Goycoolea FM. Astaxanthin: a review of its chemistry and applications. Crit Rev Food Sci Nutr. 2006;46(2):185-96. doi: 10.1080/10408690590957188.

    PubMed 16431409

Questions about this trial

What is this clinical trial studying?

A study testing astaxanthin in people with Osteoarthritis, Knee, run by Saint Luke's Health System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in PROMIS Numeric Rating Pain Scale (time frame: 20 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03664466, which also lists 54 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2022.

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