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The Effects of Resveratrol on the Complications of Patients With Hemodialysis

NCT ID: NCT03352895

Last Updated: 2017-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2017-07-31

Brief Summary

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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

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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.

Conditions

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Chronic Kidney Disease

Keywords

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Resveratrol chronic kidney disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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control

Control group will receive placebo medication therapy

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

The gel contains a mixture of glucose and maltodextrin - a complex carbohydrate - along with fat and a trace of protein.

test group

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

Group Type EXPERIMENTAL

resveratrol

Intervention Type DIETARY_SUPPLEMENT

Grape seed extract 100mg Microcrystalline Cellulose 90mg Magnesium Stearate 2mg Gelatin 100mg

Interventions

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resveratrol

Grape seed extract 100mg Microcrystalline Cellulose 90mg Magnesium Stearate 2mg Gelatin 100mg

Intervention Type DIETARY_SUPPLEMENT

Placebo

The gel contains a mixture of glucose and maltodextrin - a complex carbohydrate - along with fat and a trace of protein.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Grape seed extract Maltodextrin

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dalin Tzu Chi General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Juen-Haur Hwang, MD, PhD.

Role: STUDY_CHAIR

Dalin Tzu Chi Hospital

Locations

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Dalin Tzu Chi Hospital

Chiayi City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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B10401008

Identifier Type: -

Identifier Source: org_study_id