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Trial record 79 of 167 for:    Curcumin | curcumin

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

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ClinicalTrials.gov Identifier: NCT03223883
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : April 10, 2019
Sponsor:
Collaborators:
University of Colorado, Boulder
Stanford University
University of Colorado, Denver
Information provided by (Responsible Party):
Diana Jalal, University of Iowa

Tracking Information
First Submitted Date  ICMJE July 18, 2017
First Posted Date  ICMJE July 21, 2017
Last Update Posted Date April 10, 2019
Actual Study Start Date  ICMJE January 30, 2018
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2017)
Vascular endothelial function [ Time Frame: 12 months ]
Brachial artery flow-mediated dilation
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03223883 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2017)
  • Large artery stiffness [ Time Frame: 12 months ]
    Aortic pulse wave velocity
  • Cognitive function [ Time Frame: 12 months ]
    NIH toolbox battery
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Curcumin and Vascular and Cognitive Function in Patients With Chronic Kidney Disease
Official Title  ICMJE Curcumin Supplementation for Improving Vascular and Cognitive Function in Chronic Kidney Disease
Brief 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.
Detailed Description

Patients with chronic kidney disease (CKD) are at increased risk of death from cardiovascular disease (CVD). Inflammation, oxidative stress and vascular dysfunction (impaired endothelial function and increased large elastic artery stiffness), are highly prevalent in CKD and contribute to the high incidence of CVD in this patient population. In addition, patients with CKD suffer from high rates of cognitive decline for which we lack effective therapies. Thus, therapeutic interventions targeting inflammation, oxidative stress, vascular dysfunction, and cognitive impairment in CKD are a biomedical priority.

Curcumin is a natural polyphenol with anti-inflammatory and antioxidant characteristics. It is safe and widely-available. Preliminary data in old mice and healthy middle-aged (MA)/older adult humans indicate that curcumin administration improves endothelial dysfunction and large artery stiffness by reducing oxidative stress and inflammation. Additionally, 12 weeks of curcumin supplementation improves episodic memory in MA/older adults.

The primary goal of this R01 application is to extend previous findings in healthy MA/older adults to patients with CKD, a growing clinical population with extensive baseline vascular dysfunction and cognitive impairment who presently have few treatment options. The hypothesis is that curcumin improves vascular endothelial function and large elastic artery stiffness in MA/older adults with stage IIIb and IV CKD (estimated GFR 15-45 mL/min/1.73m2). The possible mechanisms by which curcumin improves vascular function will be evaluated as well as whether curcumin improves cognitive function in these patients.

Specific aim 1a will determine if 12 months of curcumin supplementation will improve brachial artery-flow mediated dilation (BA-FMD) (endothelial function) and aortic pulse wave velocity (aPWV) (arterial stiffness) compared to placebo (randomized placebo-controlled double-blind study). Specific aim 1b will evaluate whether the curcumin-induced improvements in BA-FMD and aPWV are mediated by reduced oxidative stress, and will evaluate the effects of curcumin on systemic and endothelial cell markers of inflammation and oxidative stress. Importantly, specific aim 2 will evaluate the effects of curcumin supplementation on cognitive function, an important complication of CKD, using the NIH Cognitive Toolbox Battery.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized Double-Blind Placebo-Controlled Clinical Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Patient, providers, and the investigative team will all be blinded to the randomization.
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Kidney Diseases
  • Cognitive Decline
Intervention  ICMJE
  • Drug: Curcumin
    Oral supplement for 12 months
    Other Name: Longvida
  • Other: Placebo
    Oral placebo for 12 months
Study Arms  ICMJE
  • Experimental: Curcumin
    Patients will receive curcumin (Lonvida) 2000 mg PO once a day
    Intervention: Drug: Curcumin
  • Placebo Comparator: Placebo
    Patients will receive placebo pill identical in appearance and taste to the supplement
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 18, 2017)
88
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2023
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Diana Jalal 7204254154 diana-jalal@uiowa.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03223883
Other Study ID Numbers  ICMJE 201710769
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Diana Jalal, University of Iowa
Study Sponsor  ICMJE Diana Jalal
Collaborators  ICMJE
  • University of Colorado, Boulder
  • Stanford University
  • University of Colorado, Denver
Investigators  ICMJE
Principal Investigator: Diana Jalal University of Iowa
PRS Account University of Iowa
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP