Trial Outcomes & Findings for Curcumin and Vascular and Cognitive Function in Patients With Chronic Kidney Disease (NCT NCT03223883)
NCT ID: NCT03223883
Last Updated: 2024-10-08
Results Overview
Brachial artery flow-mediated dilation, changed in diameter in brachial artery in response to shear stress
COMPLETED
PHASE2
94 participants
12 months
2024-10-08
Participant Flow
Study participants were recruited between June 2018 and February 2022 from the Renal Clinics at the University of Iowa Hospital and Clinics (UIHC) and the Iowa City Veterans Affairs Health Care System (VA HCS). All procedures were approved by the University of Iowa and the Iowa City VA HCS Institutional Review Boards and conducted in accordance with the Declaration of Helsinki. All participants provided written documentation of the informed consent process before study participation.
Participant milestones
| Measure |
Curcumin
Patients will receive curcumin (Lonvida) 2000 mg PO once a day
Curcumin: Oral supplement for 12 months
|
Placebo
Patients will receive placebo pill identical in appearance and taste to the supplement
Placebo: Oral placebo for 12 months
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
43
|
|
Overall Study
COMPLETED
|
37
|
38
|
|
Overall Study
NOT COMPLETED
|
8
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Curcumin and Vascular and Cognitive Function in Patients With Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
Curcumin
n=45 Participants
Patients will receive curcumin (Lonvida) 2000 mg PO once a day
Curcumin: Oral supplement for 12 months
|
Placebo
n=43 Participants
Patients will receive placebo pill identical in appearance and taste to the supplement
Placebo: Oral placebo for 12 months
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 8 • n=99 Participants
|
65 years
STANDARD_DEVIATION 8 • n=107 Participants
|
66 years
STANDARD_DEVIATION 8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
81 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=99 Participants
|
43 participants
n=107 Participants
|
88 participants
n=206 Participants
|
|
Brachial artery flow-mediated dilation
|
2.8 % change
n=99 Participants
|
2.6 % change
n=107 Participants
|
2.7 % change
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsBrachial artery flow-mediated dilation, changed in diameter in brachial artery in response to shear stress
Outcome measures
| Measure |
Curcumin
n=37 Participants
Patients will receive curcumin (Lonvida) 2000 mg PO once a day
Curcumin: Oral supplement for 12 months
|
Placebo
n=38 Participants
Patients will receive placebo pill identical in appearance and taste to the supplement
Placebo: Oral placebo for 12 months
|
|---|---|---|
|
Change in Vascular Endothelial Function at 12 Months
|
-0.1 %change
Interval -1.5 to 1.5
|
-0.7 %change
Interval -2.1 to 1.1
|
SECONDARY outcome
Timeframe: 12 monthsAortic pulse wave velocity
Outcome measures
| Measure |
Curcumin
n=37 Participants
Patients will receive curcumin (Lonvida) 2000 mg PO once a day
Curcumin: Oral supplement for 12 months
|
Placebo
n=38 Participants
Patients will receive placebo pill identical in appearance and taste to the supplement
Placebo: Oral placebo for 12 months
|
|---|---|---|
|
Large Artery Stiffness
|
0.28 m/s
Standard Deviation 2.4
|
0.36 m/s
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: 12 monthsNIH toolbox battery- Executive Function Age-Corrected Standard Score is reported (T-score): This score compares the score of the test-taker to those in the NIH Toolbox nationally representative normative sample at the same age, where a score of 100 indicates performance that was at the national average for the test-taking participant's age. Age-corrected standard scores were derived separately for children (ages 3-17) and adults (ages 18-85). A score of 115 or 85, for example, would indicate that the participant's performance is 1 SD above or below the national average, respectively, when compared with like-aged participants. Higher scores indicate better performance.
Outcome measures
| Measure |
Curcumin
n=37 Participants
Patients will receive curcumin (Lonvida) 2000 mg PO once a day
Curcumin: Oral supplement for 12 months
|
Placebo
n=38 Participants
Patients will receive placebo pill identical in appearance and taste to the supplement
Placebo: Oral placebo for 12 months
|
|---|---|---|
|
Cognitive Function
|
2.62 age-adjusted T-score
Standard Deviation 9
|
2.25 age-adjusted T-score
Standard Deviation 9.5
|
Adverse Events
Curcumin
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Curcumin
n=45 participants at risk
Patients will receive curcumin (Lonvida) 2000 mg PO once a day
Curcumin: Oral supplement for 12 months
|
Placebo
n=43 participants at risk
Patients will receive placebo pill identical in appearance and taste to the supplement
Placebo: Oral placebo for 12 months
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
15.6%
7/45 • 12 MONTHS
|
14.0%
6/43 • 12 MONTHS
|
|
Gastrointestinal disorders
Vomiting
|
8.9%
4/45 • 12 MONTHS
|
14.0%
6/43 • 12 MONTHS
|
|
Gastrointestinal disorders
Abdominal PAIN
|
13.3%
6/45 • 12 MONTHS
|
4.7%
2/43 • 12 MONTHS
|
|
General disorders
Dizziness
|
22.2%
10/45 • 12 MONTHS
|
18.6%
8/43 • 12 MONTHS
|
Additional Information
Dr. Diana Jalal
University of Iowa Carver College of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place