Clinical trial NCT03352895: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: Resveratrol
chronic kidney disease
Lead sponsor: Dalin Tzu Chi General Hospital
Sponsor class: OTHER
First posted: 2017-11-24
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Pure tone audiometry (PTA)
timeFrame: one year
Secondary outcomes:
measure: Speech Audiometry
timeFrame: one year
Other outcomes:
Locations:
city: Chiayi City
country: Taiwan
facility: Dalin Tzu Chi Hospital
Study officials:
affiliation: Dalin Tzu Chi Hospital
name: Juen-Haur Hwang, MD, PhD.
role: STUDY_CHAIR
References: