Trial Outcomes & Findings for Astaxanthin for Management of Inflammation in Knee Osteoarthritis (NCT NCT05138549)
NCT ID: NCT05138549
Last Updated: 2025-05-20
Results Overview
We will address this by conducting a prospective, double-blinded, randomized, placebo-controlled trial in which 160 patients who have been diagnosed with advanced osteoarthritis of the knee and are scheduled to undergo a total knee replacement will randomly receive a 6-week oral daily course of either astaxanthin (12 mg) or placebo prior to surgery. Levels of pro- and anti-inflammatory cytokines and chemokines within the intra-articular synovial fluid at the time of surgery will be quantified using a bioplex 23-cytokine and chemokine assay kit in post-treatment synovial fluid samples from patients receiving either astaxanthin or placebo.
TERMINATED
PHASE2/PHASE3
16 participants
6 Weeks
2025-05-20
Participant Flow
Participant milestones
| Measure |
Control: Placebo Group
Patients will receive a 6 week daily oral supply of placebo, identical in appearance to the astaxanthin supplement.
Placebo: Oral placebo identical to astaxanthin supplement
|
Experimental: Astaxanthin Supplementation Group
Patients will receive a 6 week daily oral supply of 12 mg astaxanthin supplement.
Astaxanthin: 12 mg oral astaxanthin supplement
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
6
|
|
Overall Study
COMPLETED
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Astaxanthin for Management of Inflammation in Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
Control: Placebo Group
n=10 Participants
Patients will receive a 6 week daily oral supply of placebo, identical in appearance to the astaxanthin supplement.
Placebo: Oral placebo identical to astaxanthin supplement
|
Experimental: Astaxanthin Supplementation Group
n=6 Participants
Patients will receive a 6 week daily oral supply of 12 mg astaxanthin supplement.
Astaxanthin: 12 mg oral astaxanthin supplement
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
74 years
STANDARD_DEVIATION 10.7 • n=7 Participants
|
69 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
6 participants
n=7 Participants
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 WeeksPopulation: The synovial fluid samples were being held to be batch processed at the end of the study by an outside scientific laboratory. The study was stopped early and the cytokine and chemokines testing was not done. There are no plans to analyze these samples at present or in the future. Therefore, there are no results to report for this outcome measure which is why participants analyzed for the control and experimental groups are both 0.
We will address this by conducting a prospective, double-blinded, randomized, placebo-controlled trial in which 160 patients who have been diagnosed with advanced osteoarthritis of the knee and are scheduled to undergo a total knee replacement will randomly receive a 6-week oral daily course of either astaxanthin (12 mg) or placebo prior to surgery. Levels of pro- and anti-inflammatory cytokines and chemokines within the intra-articular synovial fluid at the time of surgery will be quantified using a bioplex 23-cytokine and chemokine assay kit in post-treatment synovial fluid samples from patients receiving either astaxanthin or placebo.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 WeeksPatient reported outcomes will be collected utilizing the Patient Reported Outcome Measurement Information Systems (PROMIS) Physical Function assessment tool. Patients receiving either astaxanthin or placebo will complete PROMIS Physical Function assessment prior to starting the oral treatment regimen and just prior to surgery, following the completion of the oral treatment regimen. As the PROMIS tool has national normative data for age, sex, and condition, collection of patient-reported outcomes in this manner will allow for comparison between patients receiving astaxanthin and patients receiving the placebo as well as the general population. An increased PROMIS Physical Function score indicates an improvement in patient-reported physical function. The scale range is 0 to 100 with a mean of 50 and a standard deviation of 10. Higher values are associated with more or higher function. A score of 60 is one SD better than average. A score of 40 is one SD worse than average.
Outcome measures
| Measure |
Control: Placebo Group
n=7 Participants
Patients will receive a 6 week daily oral supply of placebo, identical in appearance to the astaxanthin supplement.
Placebo: Oral placebo identical to astaxanthin supplement
|
Experimental: Astaxanthin Supplementation Group
n=4 Participants
Patients will receive a 6 week daily oral supply of 12 mg astaxanthin supplement.
Astaxanthin: 12 mg oral astaxanthin supplement
|
|---|---|---|
|
Effect of Astaxanthin on PROMIS Physical Function Scores in Patients With Osteoarthritis Who Are Scheduled to Undergo a Total Knee Replacement Surgery.
|
40.3 score on a scale
Standard Error 2.1
|
41.9 score on a scale
Standard Error 2.3
|
SECONDARY outcome
Timeframe: 6 weeksPatient reported outcomes will be collected utilizing the Patient Reported Outcome Measurement Information Systems (PROMIS) Pain Interference assessment tool. Patients receiving either astaxanthin or placebo will complete the PROMIS Pain Interference assessment prior to starting the oral treatment regimen and just prior to surgery, following the completion of the oral treatment regimen. As the PROMIS tool has national normative data for age, sex, and condition, collection of patient-reported outcomes in this manner will allow for comparison between patients receiving astaxanthin and patients receiving the placebo as well as the general population. A decreased PROMIS Pain Interference score indicates an improvement in patient-reported pain interference. The scale range is 0 to 100 with a mean of 50 and a standard deviation of 10. Higher values are associated with more or higher pain. A score of 60 is one SD worse pain than average. A score of 40 is one SD better pain than average.
Outcome measures
| Measure |
Control: Placebo Group
n=7 Participants
Patients will receive a 6 week daily oral supply of placebo, identical in appearance to the astaxanthin supplement.
Placebo: Oral placebo identical to astaxanthin supplement
|
Experimental: Astaxanthin Supplementation Group
n=4 Participants
Patients will receive a 6 week daily oral supply of 12 mg astaxanthin supplement.
Astaxanthin: 12 mg oral astaxanthin supplement
|
|---|---|---|
|
Effect of Astaxanthin on PROMIS Pain Interference Scores in Patients With Osteoarthritis Who Are Scheduled to Undergo a Total Knee Replacement Surgery.
|
62.0 score on a scale
Standard Error 2.2
|
55.0 score on a scale
Standard Error 2.1
|
Adverse Events
Control: Placebo Group
Experimental: Astaxanthin Supplementation Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control: Placebo Group
n=10 participants at risk
Patients will receive a 6 week daily oral supply of placebo, identical in appearance to the astaxanthin supplement.
Placebo: Oral placebo identical to astaxanthin supplement
|
Experimental: Astaxanthin Supplementation Group
n=6 participants at risk
Patients will receive a 6 week daily oral supply of 12 mg astaxanthin supplement.
Astaxanthin: 12 mg oral astaxanthin supplement
|
|---|---|---|
|
Gastrointestinal disorders
Stomach pain
|
20.0%
2/10 • Number of events 2 • During study period (approximately one year)
|
33.3%
2/6 • Number of events 2 • During study period (approximately one year)
|
|
General disorders
Dizziness
|
10.0%
1/10 • Number of events 1 • During study period (approximately one year)
|
0.00%
0/6 • During study period (approximately one year)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place