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The Effects of Resveratrol on the Complications of Patients With Hemodialysis

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
resveratrol
Placebo
Sponsored by
Dalin Tzu Chi General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Kidney Disease focused on measuring Resveratrol, chronic kidney disease

Eligibility Criteria

40 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dalin Tzu Chi Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

control

test group

Arm Description

Control group will receive placebo medication therapy

resveratrol group will receive oral resveratrol (100 mg per day)

Outcomes

Primary Outcome Measures

Pure tone audiometry (PTA)
pure tone thresholds of 250, 500, 1000, 2000, 4000, 8000 Hz were measured.

Secondary Outcome Measures

Speech Audiometry
Speech reception thresholds and speech discrimination scores were tested.

Full Information

First Posted
February 7, 2017
Last Updated
November 22, 2017
Sponsor
Dalin Tzu Chi General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03352895
Brief Title
The Effects of Resveratrol on the Complications of Patients With Hemodialysis
Official Title
The Effects of Resveratrol on the Complications of Patients With Hemodialysis: a Prospective, Randomized, Double-blinded Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
November 2014 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dalin Tzu Chi General Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Resveratrol, chronic kidney disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
Placebo Comparator
Arm Description
Control group will receive placebo medication therapy
Arm Title
test group
Arm Type
Experimental
Arm Description
resveratrol group will receive oral resveratrol (100 mg per day)
Intervention Type
Dietary Supplement
Intervention Name(s)
resveratrol
Other Intervention Name(s)
Grape seed extract
Intervention Description
Grape seed extract 100mg Microcrystalline Cellulose 90mg Magnesium Stearate 2mg Gelatin 100mg
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
Maltodextrin
Intervention Description
The gel contains a mixture of glucose and maltodextrin - a complex carbohydrate - along with fat and a trace of protein.
Primary Outcome Measure Information:
Title
Pure tone audiometry (PTA)
Description
pure tone thresholds of 250, 500, 1000, 2000, 4000, 8000 Hz were measured.
Time Frame
one year
Secondary Outcome Measure Information:
Title
Speech Audiometry
Description
Speech reception thresholds and speech discrimination scores were tested.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juen-Haur Hwang, MD, PhD.
Organizational Affiliation
Dalin Tzu Chi Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Dalin Tzu Chi Hospital
City
Chiayi City
ZIP/Postal Code
66247
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

The Effects of Resveratrol on the Complications of Patients With Hemodialysis

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