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Resveratrol's Effects on Inflammation and Oxidative Stress in Chronic Kidney Disease

Primary Purpose

Chronic Renal Insufficiency

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Resveratrol
Placebo
Sponsored by
Universidade Federal Fluminense
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Renal Insufficiency focused on measuring resveratrol, oxidative stress, inflammation

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic kidney disease patients in stages 3 or 4, undergoing conservative treatment

Exclusion Criteria:

  • Patients with diabetes mellitus, AIDS, inflammatory or infectious diseases, pregnant women, smokers and those using antioxidant supplements

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Supplement B

    Supplement A

    Arm Description

    Administration of 500mg of trans-resveratrol per day, for 4 weeks

    Administration of 500mg of placebo per day, for 4 weeks

    Outcomes

    Primary Outcome Measures

    Antioxidants and anti-inflammatory biomarkers
    Get blood samples to evaluate the supplementation effects in antioxidants biomarkers (Nrf2, GPx, HO-1)

    Secondary Outcome Measures

    Inflammatory biomarkers
    Get blood samples to evaluate the supplementation effects in inflammatory biomarkers (NFkB, IL-6, TNF-alfa)

    Full Information

    First Posted
    February 19, 2015
    Last Updated
    April 29, 2015
    Sponsor
    Universidade Federal Fluminense
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02433925
    Brief Title
    Resveratrol's Effects on Inflammation and Oxidative Stress in Chronic Kidney Disease
    Official Title
    Effects of Supplementation With Resveratrol on Inflammation and Oxidative Stress of Non-dialysis Chronic Kidney Disease Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2013 (undefined)
    Primary Completion Date
    January 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Universidade Federal Fluminense

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Inflammation and oxidative stress are common findings in patients with Chronic Kidney Disease (CKD) undergoing conservative treatment, in addition to being associated with atherosclerotic process, are related also to the progression of CKD. In this regard, resveratrol, a phenolic compound with recognized antioxidant and anti-inflammatory properties, can play an important role in the control of metabolic disorders associated with CKD, since it can modulate the mechanisms involved in inflammation and oxidative stress cycle. Resveratrol is capable of promoting the activation of the transcription-related factor-2 nuclear factor erythroid factor 2 (Nrf2) , a nuclear factor with anti-inflammatory properties, and SIRT-1, a protein also associated with the reduction of inflammation. These two factors, in their turn, are able to inhibit / antagonize the activity of the nuclear factor κB (NF-kB), a transcription factor that participates in the inflammatory response. Although it is a promising treatment, there are no studies evaluating the effects of resveratrol supplementation in patients with CKD. Thus, this study aims to evaluate the effects of resveratrol supplementation on inflammation and oxidative stress in patients undergoing conservative treatment of CKD.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Renal Insufficiency
    Keywords
    resveratrol, oxidative stress, inflammation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Supplement B
    Arm Type
    Active Comparator
    Arm Description
    Administration of 500mg of trans-resveratrol per day, for 4 weeks
    Arm Title
    Supplement A
    Arm Type
    Placebo Comparator
    Arm Description
    Administration of 500mg of placebo per day, for 4 weeks
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Resveratrol
    Other Intervention Name(s)
    trans-resveratrol
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Antioxidants and anti-inflammatory biomarkers
    Description
    Get blood samples to evaluate the supplementation effects in antioxidants biomarkers (Nrf2, GPx, HO-1)
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Inflammatory biomarkers
    Description
    Get blood samples to evaluate the supplementation effects in inflammatory biomarkers (NFkB, IL-6, TNF-alfa)
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Chronic kidney disease patients in stages 3 or 4, undergoing conservative treatment Exclusion Criteria: Patients with diabetes mellitus, AIDS, inflammatory or infectious diseases, pregnant women, smokers and those using antioxidant supplements

    12. IPD Sharing Statement

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