The Effects of Resveratrol on the Complications of Patients With Hemodialysis

Study Overview
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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.

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

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Dietary Supplement: resveratrol
* Dietary Supplement: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resveratrol, chronic kidney disease