Trial · NCT02494141

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

NCT02494141, Phase 4, Completed, University of Colorado, Denver; results first posted 2022-03-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults With ADPKD. Trials, record NCT02494141. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02494141

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Curcumin Therapy to Treat Vascular Dysfunction in Children and Young Adults With ADPKD
NCT number: NCT02494141
Status: Completed
Phases: Phase 4
Enrollment: 68 participants, actual
Lead sponsor: University of Colorado, Denver
Conditions: Polycystic Kidney, Autosomal Dominant
Interventions: Curcumin, Placebo
First posted: 2015-07-10
Last updated: 2022-03-03
Results first posted: 2022-03-03

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percent Change in Brachial Artery Flow-mediated Dilation (FMD-BA)	Baseline, Month 12	co-primary endpoint
Primary	Change in Aortic Pulse-wave Velocity (aPWV) (cm/Sec)	Baseline, Month 12	co-primary endpoint
Secondary	Change in Urinary 8-iso-prostaglandin F2α (8-isoprostane)	Baseline, Month 12	Urine marker of oxidative stress. Values are normalized to urinary creatinine.
Secondary	Change in C-reactive Protein	Baseline, Month 12	Circulating marker of inflammation
Secondary	Change in Interleukin-6	Baseline, Month 12	Circulating marker of inflammation
Secondary	Percent Change in Oxidative Stress-associated Suppression of Endothelium-dependent Dilation (EDD)	Baseline, Month 12	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.
Secondary	Change in Oxidative Stress-Associated Suppression of Large Elastic Artery Stiffness	Baseline, Month 12	The influence of oxidative stress on aPWV will be determined by infusing a supraphysiological dose of ascorbic acid known to scavenge superoxide or isovolumic saline.
Other	Change in Alanine Transaminase (ALT )	month 1, 6, and 12	Liver enzymes will be monitored for safety.
Other	Change in Aspartate Aminotransferase (AST)	month 1, 6, and 12	Liver enzymes will be monitored for safety.
Other	Change in Height-corrected Total Kidney Volume	Baseline, Month 12	Total kidney volume will be measured by MRI

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent Change in Brachial Artery Flow-mediated Dilation (FMD-BA)	Baseline, Month 12		percent change	MEAN
PRIMARY	Change in Aortic Pulse-wave Velocity (aPWV) (cm/Sec)	Baseline, Month 12		cm/sec	MEAN
SECONDARY	Change in Urinary 8-iso-prostaglandin F2α (8-isoprostane)	Baseline, Month 12	Some participants were excluded because 12 month data was not collected.	mg/dl	MEAN
SECONDARY	Change in C-reactive Protein	Baseline, Month 12	Some participants were excluded because their 12 month data was not collected.	mg/L	MEAN
SECONDARY	Change in Interleukin-6	Baseline, Month 12	Some participants were excluded because 12 month data was not collected.	picograms/mL	MEAN
SECONDARY	Percent Change in Oxidative Stress-associated Suppression of Endothelium-dependent Dilation (EDD)	Baseline, Month 12	This outcome measure was only collected for a subgroup of participants	Percent change	MEAN
SECONDARY	Change in Oxidative Stress-Associated Suppression of Large Elastic Artery Stiffness	Baseline, Month 12	This outcome measure was not collected for any participants.
OTHER_PRE_SPECIFIED	Change in Alanine Transaminase (ALT )	month 1, 6, and 12
OTHER_PRE_SPECIFIED	Change in Aspartate Aminotransferase (AST)	month 1, 6, and 12
OTHER_PRE_SPECIFIED	Change in Height-corrected Total Kidney Volume	Baseline, Month 12

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percent Change in Brachial Artery Flow-mediated Dilation (FMD-BA)	Curcumin	1.14	95% Confidence Interval -0.84 to 3.13	percent change
Percent Change in Brachial Artery Flow-mediated Dilation (FMD-BA)	Placebo	0.3	95% Confidence Interval -1.34 to 2.00	percent change
Change in Aortic Pulse-wave Velocity (aPWV) (cm/Sec)	Curcumin	0.6	95% Confidence Interval -25.7 to 26.9	cm/sec
Change in Aortic Pulse-wave Velocity (aPWV) (cm/Sec)	Placebo	6.5	95% Confidence Interval -20.4 to 33.5	cm/sec
Change in Urinary 8-iso-prostaglandin F2α (8-isoprostane)	Curcumin	0.00	95% Confidence Interval -0.34 to 0.34	mg/dl
Change in Urinary 8-iso-prostaglandin F2α (8-isoprostane)	Placebo	0.27	95% Confidence Interval -0.14 to 0.69	mg/dl
Change in C-reactive Protein	Curcumin	0.21	95% Confidence Interval -0.47 to 0.88	mg/L
Change in C-reactive Protein	Placebo	0.17	95% Confidence Interval -0.36 to 0.70	mg/L
Change in Interleukin-6	Curcumin	2.24	95% Confidence Interval 1.69 to 2.80	picograms/mL
Change in Interleukin-6	Placebo	2.33	95% Confidence Interval 1.89 to 2.76	picograms/mL

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Curcumin	34
Overall Study	STARTED	Placebo	34
Overall Study	COMPLETED	Curcumin	28
Overall Study	COMPLETED	Placebo	29
Overall Study	NOT COMPLETED	Curcumin	6
Overall Study	NOT COMPLETED	Placebo	5

Source ClinicalTrials.gov

Adverse events14

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Gastrointestinal issues	Gastrointestinal disorders	Curcumin	7	34	7
other	Gastrointestinal issues	Gastrointestinal disorders	Placebo	7	34	7
other	Warming or redness of face	Vascular disorders	Curcumin	2	34	2
other	Warming or redness of face	Vascular disorders	Placebo	0	34	0
other	Tingling of tongue/mouth	Respiratory, thoracic and mediastinal disorders	Curcumin	2	34	2
other	Tingling of tongue/mouth	Respiratory, thoracic and mediastinal disorders	Placebo	0	34	0
other	Headache	General disorders	Curcumin	1	34	1
other	Headache	General disorders	Placebo	1	34	1
other	Dry Mouth	Skin and subcutaneous tissue disorders	Curcumin	0	34	0
other	Dry Mouth	Skin and subcutaneous tissue disorders	Placebo	1	34	1

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Curcumin	0	34
Total, all-cause mortality	Placebo	0	34
Total, other adverse events	Curcumin	15	34
Total, other adverse events	Placebo	9	34
Total, serious adverse events	Curcumin	0	34
Total, serious adverse events	Placebo	0	34

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
34907021	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Curcumin vs Placebo: deaths from any cause	Trial comparisons
Curcumin vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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GET https://conductscience.org/api/trials/v1/NCT02494141/registered

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