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NCT03223883

Curcumin and Vascular and Cognitive Function in Patients With Chronic Kidney Disease

Completed Phase 2 Results posted Last updated 8 October 2024
What this trial tests

Phase 2 trial testing Curcumin in Chronic Kidney Diseases in 94 participants. Completed in 25 January 2023.

Timeline
1 June 2018
Primary endpoint
25 January 2023
25 January 2023

Quick facts

Lead sponsorDiana Jalal
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment94
Start date1 June 2018
Primary completion25 January 2023
Estimated completion25 January 2023
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Diana Jalal

Who can join

Adults 45 to 74, any sex, with Chronic Kidney Diseases or Cognitive Decline. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Vascular Endothelial Function at 12 Months Primary · 12 months

Brachial artery flow-mediated dilation, changed in diameter in brachial artery in response to shear stress

GroupValue95% CI
Curcumin-0.1-1.5 – 1.5
Placebo-0.7-2.1 – 1.1
Large Artery Stiffness Secondary · 12 months

Aortic pulse wave velocity

GroupValue95% CI
Curcumin0.28± 2.4
Placebo0.36± 4.2
Cognitive Function Secondary · 12 months

NIH 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 comp

GroupValue95% CI
Curcumin2.62± 9
Placebo2.25± 9.5

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 MONTHS. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Curcumin
Serious: 0/45 (0%)
Deaths: 1/45
Placebo
Serious: 0/43 (0%)
Deaths: 0/43
Other adverse events (4 terms — click to expand)

ReactionSystemCurcuminPlacebo
DizzinessGeneral disorders
NauseaGastrointestinal disorders
VomitingGastrointestinal disorders
Abdominal PAINGastrointestinal disorders

Data from ClinicalTrials.gov NCT03223883 adverse events section.

Sponsor's own description

The proposed research is clinical study evaluating the therapeutic benefits of curcumin on vascular function in patients with chronic kidney disease (CKD). The study aims to establish that curcumin will improve endothelial function and reduce large artery stiffness by reducing oxidative stress and in conjunction with lowering markers of inflammation and oxidative stress. In addition, the study will evaluate the potential benefit of curcumin on cognitive function in patients with CKD.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Detection of pro angiogenic and inflammatory biomarkers in patients with CKD.
    Jalal D, Sanford B, Renner B, Ten Eyck P, et al · · 2021 · cited 22× · PMID 33888746 · DOI 10.1038/s41598-021-87710-0
  2. The Mitochondrion: A Promising Target for Kidney Disease.
    Tanriover C, Copur S, Ucku D, Cakir AB, et al · · 2023 · cited 19× · PMID 36839892 · DOI 10.3390/pharmaceutics15020570
  3. Promoting healthy cardiovascular aging: emerging topics.
    Clayton ZS, Craighead DH, Darvish S, Coppock M, et al · · 2022 · cited 19× · PMID 36337728 · DOI 10.20517/jca.2022.27
  4. Putative role of natural products as Protein Kinase C modulator in different disease conditions.
    Singh RK, Kumar S, Tomar MS, Verma PK, et al · · 2021 · cited 11× · PMID 34216003 · DOI 10.1007/s40199-021-00401-z
  5. Effect of Cellular Senescence in Disease Progression and Transplantation: Immune Cells and Solid Organs.
    Kirchner VA, Badshah JS, Hong SK, Martinez O, et al · · 2024 · cited 8× · PMID 37953486 · DOI 10.1097/tp.0000000000004838
  6. Curcumin Supplementation and Vascular and Cognitive Function in Chronic Kidney Disease: A Randomized Controlled Trial.
    Gimblet CJ, Kruse NT, Geasland K, Michelson J, et al · · 2024 · cited 4× · PMID 39199229 · DOI 10.3390/antiox13080983
  7. Evaluation of Urinary Kidney Tubule Biomarkers With Curcumin in CKD.
    Gimblet CJ, Sun M, Geasland K, Akbari S, et al · · 2025 · PMID 40485692 · DOI 10.1016/j.ekir.2025.02.016

Verify or expand the search:

Other trials of Curcumin

Trials testing the same drug.

Other recruiting trials for Chronic Kidney Diseases

Currently open trials in the same condition.

Other Diana Jalal trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing