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 : February 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Diseases Cognitive Decline||Drug: Curcumin Other: Placebo||Phase 2|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||88 participants|
|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.|
|Official Title:||Curcumin Supplementation for Improving Vascular and Cognitive Function in Chronic Kidney Disease|
|Actual Study Start Date :||January 30, 2018|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||August 31, 2023|
Patients will receive curcumin (Lonvida) 2000 mg PO once a day
Oral supplement for 12 months
Other Name: Longvida
Placebo Comparator: Placebo
Patients will receive placebo pill identical in appearance and taste to the supplement
Oral placebo for 12 months
- Vascular endothelial function [ Time Frame: 12 months ]Brachial artery flow-mediated dilation
- Large artery stiffness [ Time Frame: 12 months ]Aortic pulse wave velocity
- Cognitive function [ Time Frame: 12 months ]NIH toolbox battery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03223883
|Contact: Diana Jalalemail@example.com|
|United States, Iowa|
|University of Iowa||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Diana I Jalal, MD 319-356-4113 firstname.lastname@example.org|
|Contact: Debra O'Connell, BA 319-356-1693 email@example.com|
|Principal Investigator: Diana I Jalal, MD|
|Principal Investigator:||Diana Jalal||University of Iowa|