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Trial record 13 of 81 for:    extract | maltodextrin

The Effects of Resveratrol on the Complications of Patients With Hemodialysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03352895
Recruitment Status : Completed
First Posted : November 24, 2017
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):
Dalin Tzu Chi General Hospital

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Dietary Supplement: resveratrol Dietary Supplement: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effects of Resveratrol on the Complications of Patients With Hemodialysis: a Prospective, Randomized, Double-blinded Clinical Trial
Actual Study Start Date : November 2014
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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 Name: 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 Name: Grape seed extract




Primary Outcome Measures :
  1. Pure tone audiometry (PTA) [ Time Frame: one year ]
    pure tone thresholds of 250, 500, 1000, 2000, 4000, 8000 Hz were measured.


Secondary Outcome Measures :
  1. Speech Audiometry [ Time Frame: one year ]
    Speech reception thresholds and speech discrimination scores were tested.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03352895


Locations
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Taiwan
Dalin Tzu Chi Hospital
Chiayi City, Taiwan, 66247
Sponsors and Collaborators
Dalin Tzu Chi General Hospital
Investigators
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Study Chair: Juen-Haur Hwang, MD, PhD. Dalin Tzu Chi Hospital

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Responsible Party: Dalin Tzu Chi General Hospital
ClinicalTrials.gov Identifier: NCT03352895     History of Changes
Other Study ID Numbers: B10401008
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Dalin Tzu Chi General Hospital:
Resveratrol
chronic kidney disease
Additional relevant MeSH terms:
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Grape Seed Extract
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Resveratrol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents