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Resveratrol and Vascular Function in CKD

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ClinicalTrials.gov Identifier: NCT03597568
Recruitment Status : Recruiting
First Posted : July 24, 2018
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Diana Jalal, University of Iowa

Tracking Information
First Submitted Date  ICMJE July 13, 2018
First Posted Date  ICMJE July 24, 2018
Last Update Posted Date August 21, 2019
Actual Study Start Date  ICMJE January 1, 2019
Estimated Primary Completion Date August 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2018)
  • Vascular endothelial function [ Time Frame: 6 weeks ]
    Brachial artery flow-mediated dilation
  • Functional work capacity [ Time Frame: 6 weeks ]
    6-minute walk test
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03597568 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2018)
Oxidative stress [ Time Frame: 6 weeks ]
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 Resveratrol and Vascular Function in CKD
Official Title  ICMJE Effect of 6 Weeks Resveratrol Supplementation on Vascular Function in CKD
Brief Summary The proposed research is clinical study evaluating the therapeutic benefits of resveratrol on vascular function in patients with chronic kidney disease (CKD). The study aims to establish that resveratrol will improve endothelial function and functional performance by reducing oxidative stress and in conjunction with lowering markers of inflammation and oxidative stress.
Detailed Description

Patients with chronic kidney disease (CKD) have an exceptionally high risk for cardiovascular disease (CVD), and are 10 times more likely to die from CVD prior to requiring dialysis or kidney transplantation. 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 in CKD are a priority.

Wine intake, which is known to be rich in various polyphenolic compounds, might have a variety of health benefits. Among these polyphenols, the stilbene derivative resveratrol (RSV), a naturally occurring polyphenol found in grapes and red wine, has recently come to light, as it has been shown to exert potent anti-diabetic, anti-oxidative and anti-inflammatory actions. Importantly, recent studies have demonstrated that resveratrol is well-tolerated (37) and may confer similar benefits in individuals at high risk of CVD, such as improved endothelial function in individuals with metabolic syndrome (i.e. diabetes)

The primary goal of this application is to determine whether 6 wks resveratrol (RSV) supplementation improves vascular function by reducing oxidative stress in a randomized, double-blind, cross-over study of 25 patients with diabetic kidney disease. The investigators hypothesize that: 1) 6 wks RSV will improve vascular function as measured via BA-FMD vs. placebo and 2) that the improvement in vascular function will be related, at least partially, to a reduction in oxidative stress.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Kidney Diseases
  • Endothelial Dysfunction
Intervention  ICMJE
  • Dietary Supplement: Resveratrol
    Oral supplementation for 6 weeks
  • Other: Placebo
    Oral supplementation for 6 weeks
Study Arms  ICMJE
  • Experimental: Resveratrol
    Patients will receive resveratrol 500 mg PO once a day
    Intervention: Dietary Supplement: Resveratrol
  • 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 13, 2018)
25
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2020
Estimated Primary Completion Date August 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • CKD stage III (estimated GFR: 30-60 mL/MIN/1.73m2)
  • Able to give informed consent
  • Angiotensin converting enzyme inhibitor or angiotensin II receptor bloocker for > 3 month prior to the study
  • Type II diabetes mellitus

Exclusion Criteria:

  • Consuming > 2 glasses/day red wine and/or taking resveratrol or vitamin C supplement in the past 12 months
  • Life expectancy <1 year
  • BMI >40 kg/m2 1
  • Pregnant, breastfeeding, or unwilling to use adequate birth control
  • Uncontrolled hypertension; blood pressure > 140/90
  • Uncontrolled type II DM; AIC > 8.5
  • Currently taking anticoagulants including: coumadin, dalteparin, enoxaparin, haparin, and plavix.
  • Severe liver disease
  • Severe systolic heart failure
  • Hospitalization within the last 3 months
  • Active infection or antibiotic therapy
  • Immunosuppressive therapy within the last year
  • Currently partaking in another research study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Nicholas Kruse, Ph.D. 419-966-2797 nicholas-kruse-1@uiowa.edu
Contact: Diana Jalal, MD 319-356-4113 diana-jalal@uiowa.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03597568
Other Study ID Numbers  ICMJE RSV
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Diana Jalal, University of Iowa
Study Sponsor  ICMJE Diana Jalal
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Iowa
Verification Date August 2019

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