Chronic Kidney DiseaseNCT03352895
The Effects of Resveratrol on the Complications of Patients With Hemodialysis
A study testing resveratrol in people with Chronic Kidney Disease, run by Dalin Tzu Chi General Hospital at 1 site in Taiwan.
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). Read more about this study
- Who is it for?
- Ages 40 to 69 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- resveratrol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2014to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Resveratrol on the Complications of Patients With Hemodialysis: a Prospective, Randomized, Double-blinded Clinical Trial
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.
Read the 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.
- Conditions
- Chronic Kidney Disease
- Being tested
- resveratrol, Placebo
- Keywords
- Resveratrol, chronic kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resveratrolDietary supplement
Also called Grape seed extract
Grape seed extract 100mg Microcrystalline Cellulose 90mg Magnesium Stearate 2mg Gelatin 100mg
PlaceboDietary supplement
Also called Maltodextrin
The gel contains a mixture of glucose and maltodextrin - a complex carbohydrate - along with fat and a trace of protein.
| Study group | Role | What they receive |
|---|---|---|
| control | Placebo comparator | Control group will receive placebo medication therapy Receives: Dietary Supplement: Placebo |
| test group | Experimental | resveratrol group will receive oral resveratrol (100 mg per day) Receives: Dietary Supplement: resveratrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pure tone audiometry (PTA)
pure tone thresholds of 250, 500, 1000, 2000, 4000, 8000 Hz were measured.
Measured: one year
Secondary outcomes (1)
Speech Audiometry
Speech reception thresholds and speech discrimination scores were tested.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study startNov 2014
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalin Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juen-Haur Hwang, MD, PhD., Study chair, Dalin Tzu Chi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352895
- Sponsor's protocol ID
- B10401008
- Status last verified
- Oct 2017
- First submitted
- 7 Feb 2017
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Resveratrol on the Complications of Patients With Hemodialysis: a Prospective, Randomized, Double-blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT03352895
- Acronym / sponsor ID
- B10401008
- Conditions
- Chronic Kidney Disease
- Keywords
- Resveratrol, chronic kidney disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Dalin Tzu Chi General HospitalUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 24 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Placebo comparator | Dietary Supplement: PlaceboControl group will receive placebo medication therapy |
| test group | Experimental | Dietary Supplement: resveratrolresveratrol group will receive oral resveratrol (100 mg per day) |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| resveratrolAlso: Grape seed extractGrape seed extract 100mg Microcrystalline Cellulose 90mg Magnesium Stearate 2mg Gelatin 100mg | Dietary supplement | test group |
| PlaceboAlso: MaltodextrinThe gel contains a mixture of glucose and maltodextrin - a complex carbohydrate - along with fat and a trace of protein. | Dietary supplement | control |
Primary outcome
Pure tone audiometry (PTA)
Time frame: one year
pure tone thresholds of 250, 500, 1000, 2000, 4000, 8000 Hz were measured.
1 secondary outcome
Speech Audiometry
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juen-Haur Hwang, MD, PhD. study chair
Dalin Tzu Chi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing resveratrol in people with Chronic Kidney Disease, run by Dalin Tzu Chi General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pure tone audiometry (PTA) (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2017.