Trial Outcomes & Findings for Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults With ADPKD (NCT NCT02494141)

Results Overview

co-primary endpoint

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

68 participants

Primary outcome timeframe

Baseline, Month 12

Results posted on

2022-03-03

Participant Flow

Participant milestones

Participant milestones
Measure	Curcumin 25/mg/kg per day for 1 year. Curcumin: Dietary Supplement	Placebo Equivalent placebo for 1 year. Placebo
Overall Study STARTED	34	34
Overall Study COMPLETED	28	29
Overall Study NOT COMPLETED	6	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults With ADPKD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Curcumin n=34 Participants 25/mg/kg per day for 1 year. Curcumin: Dietary Supplement	Placebo n=34 Participants Equivalent placebo for 1 year. Placebo	Total n=68 Participants Total of all reporting groups
Age, Continuous	18 years STANDARD_DEVIATION 6 • n=93 Participants	19 years STANDARD_DEVIATION 5 • n=4 Participants	18 years STANDARD_DEVIATION 5 • n=27 Participants
Sex: Female, Male Female	19 Participants n=93 Participants	18 Participants n=4 Participants	37 Participants n=27 Participants
Sex: Female, Male Male	15 Participants n=93 Participants	16 Participants n=4 Participants	31 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants	4 Participants n=4 Participants	6 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=93 Participants	30 Participants n=4 Participants	62 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	33 Participants n=93 Participants	32 Participants n=4 Participants	65 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	34 participants n=93 Participants	34 participants n=4 Participants	68 participants n=27 Participants
Estimated Glomerular Filtration Rate	115 ml/minute/1.73m^2 STANDARD_DEVIATION 16 • n=93 Participants	118 ml/minute/1.73m^2 STANDARD_DEVIATION 19 • n=4 Participants	117 ml/minute/1.73m^2 STANDARD_DEVIATION 17 • n=27 Participants

PRIMARY outcome

Timeframe: Baseline, Month 12

co-primary endpoint

Outcome measures

Outcome measures
Measure	Curcumin n=34 Participants 25/mg/kg per day for 1 year. Curcumin: Dietary Supplement	Placebo n=34 Participants Equivalent placebo for 1 year. Placebo
Percent Change in Brachial Artery Flow-mediated Dilation (FMD-BA)	1.14 percent change Interval -0.84 to 3.13	0.3 percent change Interval -1.34 to 2.0

PRIMARY outcome

Timeframe: Baseline, Month 12

co-primary endpoint

Outcome measures

Outcome measures
Measure	Curcumin n=34 Participants 25/mg/kg per day for 1 year. Curcumin: Dietary Supplement	Placebo n=34 Participants Equivalent placebo for 1 year. Placebo
Change in Aortic Pulse-wave Velocity (aPWV) (cm/Sec)	0.6 cm/sec Interval -25.7 to 26.9	6.5 cm/sec Interval -20.4 to 33.5

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: Some participants were excluded because 12 month data was not collected.

Urine marker of oxidative stress. Values are normalized to urinary creatinine.

Outcome measures

Outcome measures
Measure	Curcumin n=28 Participants 25/mg/kg per day for 1 year. Curcumin: Dietary Supplement	Placebo n=29 Participants Equivalent placebo for 1 year. Placebo
Change in Urinary 8-iso-prostaglandin F2α (8-isoprostane)	0.00 mg/dl Interval -0.34 to 0.34	0.27 mg/dl Interval -0.14 to 0.69

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: Some participants were excluded because their 12 month data was not collected.

Circulating marker of inflammation

Outcome measures

Outcome measures
Measure	Curcumin n=27 Participants 25/mg/kg per day for 1 year. Curcumin: Dietary Supplement	Placebo n=29 Participants Equivalent placebo for 1 year. Placebo
Change in C-reactive Protein	0.21 mg/L Interval -0.47 to 0.88	0.17 mg/L Interval -0.36 to 0.7

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: Some participants were excluded because 12 month data was not collected.

Circulating marker of inflammation

Outcome measures

Outcome measures
Measure	Curcumin n=27 Participants 25/mg/kg per day for 1 year. Curcumin: Dietary Supplement	Placebo n=29 Participants Equivalent placebo for 1 year. Placebo
Change in Interleukin-6	2.24 picograms/mL Interval 1.69 to 2.8	2.33 picograms/mL Interval 1.89 to 2.76

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: This outcome measure was only collected for a subgroup of participants

The influence of oxidative stress on FMD-BA will be determined by infusing a supraphysiological dose of ascorbic acid known to scavenge superoxide or isovolumic saline. The outcome measure describes the value of the percent change with ascorbic acid compared to saline observed at baseline and the value of the percent change with ascorbic acid compared to saline at the month 12 timepoint.

Outcome measures

Outcome measures
Measure	Curcumin n=12 Participants 25/mg/kg per day for 1 year. Curcumin: Dietary Supplement	Placebo n=12 Participants Equivalent placebo for 1 year. Placebo
Percent Change in Oxidative Stress-associated Suppression of Endothelium-dependent Dilation (EDD) Baseline	3.0 Percent change Standard Deviation 0.95	1.7 Percent change Standard Deviation 3.0
Percent Change in Oxidative Stress-associated Suppression of Endothelium-dependent Dilation (EDD) Month 12	1.1 Percent change Standard Deviation 3.5	1.4 Percent change Standard Deviation 2.6

SECONDARY outcome

Timeframe: Baseline, Month 12

Population: This outcome measure was not collected for any participants.

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Curcumin n=34 participants at risk 25/mg/kg per day for 1 year. Curcumin: Dietary Supplement	Placebo n=34 participants at risk Equivalent placebo for 1 year. Placebo
Gastrointestinal disorders Gastrointestinal issues	20.6% 7/34 • Number of events 7 • 12 Months Rows listed to include multiple adverse events (i.e., "Flatulence, constipation, diarrhea, or nausea") were monitored/assessed in this manner.	20.6% 7/34 • Number of events 7 • 12 Months Rows listed to include multiple adverse events (i.e., "Flatulence, constipation, diarrhea, or nausea") were monitored/assessed in this manner.
Vascular disorders Warming or redness of face	5.9% 2/34 • Number of events 2 • 12 Months Rows listed to include multiple adverse events (i.e., "Flatulence, constipation, diarrhea, or nausea") were monitored/assessed in this manner.	0.00% 0/34 • 12 Months Rows listed to include multiple adverse events (i.e., "Flatulence, constipation, diarrhea, or nausea") were monitored/assessed in this manner.
Respiratory, thoracic and mediastinal disorders Tingling of tongue/mouth	5.9% 2/34 • Number of events 2 • 12 Months Rows listed to include multiple adverse events (i.e., "Flatulence, constipation, diarrhea, or nausea") were monitored/assessed in this manner.	0.00% 0/34 • 12 Months Rows listed to include multiple adverse events (i.e., "Flatulence, constipation, diarrhea, or nausea") were monitored/assessed in this manner.
General disorders Headache	2.9% 1/34 • Number of events 1 • 12 Months Rows listed to include multiple adverse events (i.e., "Flatulence, constipation, diarrhea, or nausea") were monitored/assessed in this manner.	2.9% 1/34 • Number of events 1 • 12 Months Rows listed to include multiple adverse events (i.e., "Flatulence, constipation, diarrhea, or nausea") were monitored/assessed in this manner.
Skin and subcutaneous tissue disorders Dry Mouth	0.00% 0/34 • 12 Months Rows listed to include multiple adverse events (i.e., "Flatulence, constipation, diarrhea, or nausea") were monitored/assessed in this manner.	2.9% 1/34 • Number of events 1 • 12 Months Rows listed to include multiple adverse events (i.e., "Flatulence, constipation, diarrhea, or nausea") were monitored/assessed in this manner.
Skin and subcutaneous tissue disorders Skin irritation	2.9% 1/34 • Number of events 1 • 12 Months Rows listed to include multiple adverse events (i.e., "Flatulence, constipation, diarrhea, or nausea") were monitored/assessed in this manner.	0.00% 0/34 • 12 Months Rows listed to include multiple adverse events (i.e., "Flatulence, constipation, diarrhea, or nausea") were monitored/assessed in this manner.
Eye disorders Eye redness, dryness, or swelling	5.9% 2/34 • Number of events 2 • 12 Months Rows listed to include multiple adverse events (i.e., "Flatulence, constipation, diarrhea, or nausea") were monitored/assessed in this manner.	0.00% 0/34 • 12 Months Rows listed to include multiple adverse events (i.e., "Flatulence, constipation, diarrhea, or nausea") were monitored/assessed in this manner.

Additional Information

Kristen Nowak, Ph.D.

University of Colorado Denver | Anschutz

Phone: 303-724-1111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place