The Effects of Resveratrol on the Complications of Patients With Hemodialysis
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|ClinicalTrials.gov Identifier: NCT03352895|
Recruitment Status : Completed
First Posted : November 24, 2017
Last Update Posted : November 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease||Dietary Supplement: resveratrol Dietary Supplement: Placebo||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|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|
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
- Pure tone audiometry (PTA) [ Time Frame: one year ]pure tone thresholds of 250, 500, 1000, 2000, 4000, 8000 Hz were measured.
- Speech Audiometry [ Time Frame: one year ]Speech reception thresholds and speech discrimination scores were tested.
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
|Dalin Tzu Chi Hospital|
|Chiayi City, Taiwan, 66247|
|Study Chair:||Juen-Haur Hwang, MD, PhD.||Dalin Tzu Chi Hospital|