Skip to main content
OpenTrials
Completed

NCT Number: NCT03352895

The Effects of Resveratrol on the Complications of Patients With Hemodialysis

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resveratrol

Dietary Supplement

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

Other names: Grape seed extract

Placebo

Dietary Supplement

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

Other names: Maltodextrin

Primary outcomes

  1. Pure tone audiometry (PTA)

    Time frame: one year

    pure tone thresholds of 250, 500, 1000, 2000, 4000, 8000 Hz were measured.

Secondary outcomes

  1. Speech Audiometry

    Time frame: one year

    Speech reception thresholds and speech discrimination scores were tested.

Sponsors and collaborators

Lead sponsor

Dalin Tzu Chi General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 24, 2017
Registry last updated
Nov 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.