The Effects of Resveratrol on the Complications of Patients With Hemodialysis
1 other identifier
interventional
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedFirst Posted
Study publicly available on registry
November 24, 2017
CompletedNovember 24, 2017
October 1, 2017
2.7 years
February 7, 2017
November 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pure tone audiometry (PTA)
pure tone thresholds of 250, 500, 1000, 2000, 4000, 8000 Hz were measured.
one year
Secondary Outcomes (1)
Speech Audiometry
one year
Study Arms (2)
control
PLACEBO COMPARATORControl group will receive placebo medication therapy
test group
EXPERIMENTALresveratrol group will receive oral resveratrol (100 mg per day)
Interventions
Grape seed extract 100mg Microcrystalline Cellulose 90mg Magnesium Stearate 2mg Gelatin 100mg
The gel contains a mixture of glucose and maltodextrin - a complex carbohydrate - along with fat and a trace of protein.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dalin Tzu Chi Hospital
Chiayi City, 66247, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Juen-Haur Hwang, MD, PhD.
Dalin Tzu Chi Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2017
First Posted
November 24, 2017
Study Start
November 1, 2014
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
November 24, 2017
Record last verified: 2017-10