The Effects of Resveratrol on the Complications of Patients With Hemodialysis

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03352895
• Other study ID #: B10401008
• Status: Completed
• Phase: N/A
• First received: February 7, 2017
• Last updated: November 22, 2017
• Start date: November 2014
• Est. completion date: July 2017

Study information

• Verified date: October 2017
• Source: Dalin Tzu Chi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• resveratrol
Grape seed extract 100mg Microcrystalline Cellulose 90mg Magnesium Stearate 2mg Gelatin 100mg
• Placebo
The gel contains a mixture of glucose and maltodextrin - a complex carbohydrate - along with fat and a trace of protein.

Locations

Country	Name	City	State
Taiwan	Dalin Tzu Chi Hospital	Chiayi City

Sponsors (1)

Lead Sponsor	Collaborator
Dalin Tzu Chi General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pure tone audiometry (PTA)	pure tone thresholds of 250, 500, 1000, 2000, 4000, 8000 Hz were measured.	one year
Secondary	Speech Audiometry	Speech reception thresholds and speech discrimination scores were tested.	one year