Phase 2
N=88
Curcumin and Vascular and Cognitive Function in Patients With Chronic Kidney Disease
Chronic Kidney Diseases · Cognitive Decline
Bottom Line
View on ClinicalTrials.gov: NCT03223883 ↗Enrolled (actual)
88
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Change in Vascular Endothelial Function at 12 Months — -0.1; -0.7 %change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Curcumin (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Diana Jalal
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Vascular Endothelial Function at 12 Months |
-0.1; -0.7 | — |
| SECONDARY Large Artery Stiffness |
0.28; 0.36 | — |
| SECONDARY Cognitive Function |
2.62; 2.25 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- CKD stage IIIB and IV
- BMI<35 kg/m2
- Able to give informed consent
Exclusion Criteria
- Consuming a diet rich in curcumin or taking curcumin supplements in the past 12 months
- Life expectancy <1 year
- Pregnant, breastfeeding, or unwilling to use adequate birth control
- Uncontrolled hypertension
- Severe liver disease
- Severe congestive heart failure
- Hospitalization within the last 3 months
- Active infection or antibiotic therapy
- Immunosuppressive therapy within the last year
Data sourced from ClinicalTrials.gov (NCT03223883). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.