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Clinical Trials/NCT02433925
NCT02433925CompletedPhase 3

Effects of Supplementation With Resveratrol on Inflammation and Oxidative Stress of Non-dialysis Chronic Kidney Disease Patients

Universidade Federal Fluminense0 sites20 target enrollmentStarted: January 1, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
20
Primary Endpoint
Antioxidants and anti-inflammatory biomarkers

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
45 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Supplement A

Placebo Comparator

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

Intervention: Placebo (Dietary Supplement)

Supplement B

Active Comparator

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

Intervention: Resveratrol (Dietary Supplement)

Outcomes

Primary Outcomes

Antioxidants and anti-inflammatory biomarkers

Time Frame: 4 weeks

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

Secondary Outcomes

  • Inflammatory biomarkers(4 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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