The Effects of Resveratrol on the Complications of Patients With Hemodialysis

The Effects of Resveratrol on the Complications of Patients With Hemodialysis: a Prospective, Randomized, Double-blinded Clinical Trial

Participants'll include 140 adult patients with CKD and receiving hemodialysis in our hospital, and divided them into 2 groups. Control group will receive placebo medication therapy; resveratrol group will receive oral resveratrol (100 mg per day). All participants will receive either treatment for 1year, and receive examinations of pure tone audiometry, speech reception thresholds, and speech discrimination score.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: resveratrol

Detailed Description

Patients with chronic kidney disease (CKD) often suffered from hearing impairment, vertigo/dizziness, cognitive degeneration, cardiovascular diseases. In addition, compared to patients without CKD, the longevity of patients with CKD was also shorter. The mechanism underlying the complications of CKD were very complicated, but were generally associated with uremic toxins, tissue hypoxia, free radicals damages. Meanwhile, some co-morbidities, for example, diabetes mellitus, hypertension, atherosclerosis, would also worsen the complications of CKD. However, only limited methods were reported to have beneficial effects on renal function and its complications. For, example, controlling co-morbidities of CKD, avoiding nephrotoxic substances, and dialysis.

Resveratrol, it could prevent deterioration of cardiovascular diseases and cancer progression. But, the beneficial effects of resveratrol on hearing impairment, tinnitus, vertigo/dizziness, cognitive degeneration, cancer development, death in patients with CKD were also unclear.

This study aimed to investigate the beneficial effects of resveratrol on hearing impairment in patients with CKD by a prospective, randomized, double-blinded clinical trial design.

Participants'll include 140 adult patients with CKD and receiving hemodialysis in our hospital, and divided them into 2 groups. Control group will receive placebo medication therapy; resveratrol group will receive oral resveratrol (100 mg per day). All patients will receive either treatment for 1year, and receive examinations of pure tone audiometry, speech reception thresholds, and speech discrimination score.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Chiayi City, Taiwan, 66247
    • Dalin Tzu Chi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 67 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with chronic kidney disease (CKD) and routine hemodialysis
• Age limits 40~69 years old
• Normal hearing or symmetrical sensorineural hearing loss, all ears frequency differences are less than 15 dB

Exclusion Criteria:

• Life can not take care of themselves or the bed of a patient
• Acceptance of peritoneal dialysis patients
• Moderate hearing loss (pure tone average hearing threshold greater than 50 dB)
• Moderate or severe cognitive impairment (Mini-Mental State Examination score less than 21 points)
• The details of the study can not understand or can not fit the patient examination.
• A history of alcohol or drug abuse
• The high ambient noise exposure history
• Poor guide backbone pure tone hearing thresholds greater than 10 decibels, trying to listen to 4 kilohertz air conduction threshold is greater than 8 kilohertz air conduction threshold value of 20 dB
• Before the age of 30 have hearing loss
• Had a stroke, myocardial infarction, a history of cancer
• Pregnant woman

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control; Control group will receive placebo medication therapy	Dietary supplement: Placebo; The gel contains a mixture of glucose and maltodextrin - a complex carbohydrate - along with fat and a trace of protein.; Other Names: Maltodextrin
Experimental: test group; resveratrol group will receive oral resveratrol (100 mg per day)	Dietary supplement: resveratrol; Grape seed extract 100mg Microcrystalline Cellulose 90mg Magnesium Stearate 2mg Gelatin 100mg; Other Names: Grape seed extract

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pure tone audiometry (PTA)	pure tone thresholds of 250, 500, 1000, 2000, 4000, 8000 Hz were measured.	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speech Audiometry	Speech reception thresholds and speech discrimination scores were tested.	one year

Collaborators and Investigators

• Sponsor: Dalin Tzu Chi General Hospital
• Investigators: Study Chair: Juen-Haur Hwang, MD, PhD., Dalin Tzu Chi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2014
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: February 7, 2017
• First Submitted That Met QC Criteria: November 22, 2017
• First Posted (Actual): November 24, 2017

Study Record Updates

• Last Update Posted (Actual): November 24, 2017
• Last Update Submitted That Met QC Criteria: November 22, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: chronic kidney disease; Resveratrol
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Antineoplastic Agents; Protective Agents; Antineoplastic Agents, Phytogenic; Antioxidants; Grape Seed Extract; Resveratrol
• Other Study ID Numbers: B10401008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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.: Yes