Oxidative StressNCT01408680
CoQ10 Biomarker Trial
A study testing Coenzyme Q10 in people with Oxidative Stress and Inflammation, run by University of Washington at 1 site in United States.
Trial summary
The investigators believe that relieving the oxidative stress experienced by hemodialysis patients may help improve cardiovascular health. In this study, the investigators hypothesize that administration of coenzyme Q10, as a targeted antioxidant therapy, will ameliorate the excessive oxidative stress experienced by… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Oxidative Stress, Inflammation, Endothelial Dysfunction
- What is being tested?
- Coenzyme Q10
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Dec 2013
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with end-stage renal disease receiving thrice weekly hemodialysis
- Age ≥ 18 or ≤ 85 years
- Life expectancy greater than one year
- Ability to understand and provide informed consent for participation in the study
Who cannot join
- History of poor adherence to hemodialysis or medical regimen
- Prisoners, patients with significant mental illness, and other vulnerable populations
- AIDS (HIV seropositivity is not an exclusion criteria)
- Active malignancy excluding basal cell carcinoma of the skin
- Gastrointestinal dysfunction requiring parenteral nutrition
- History of functional kidney transplant < 6 months prior to study entry
Show all 13Show fewer
- Anticipated live donor kidney transplant
- Patients taking vitamin E supplements > 60 IU/day, vitamin C > 150 mg/day or other antioxidant or nutritional supplements
- Incident hemodialysis patients (defined as within 90 days of dialysis initiation)
- Patients hospitalized for more than 5 days within the past 30 days.
- Patients being dialyzed with a tunneled catheter as a temporary vascular access
- Patients with a history of a major atherosclerotic event (defined as combined incidence of myocardial infarction, urgent target-vessel revascularization, coronary bypass surgery, and stroke) within six months
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Effect of the Dietary Supplement Coenzyme Q10 on Biomarkers of Oxidative Stress, Systemic Inflammation, and Endothelial Function in Hemodialysis Patients
The investigators believe that relieving the oxidative stress experienced by hemodialysis patients may help improve cardiovascular health.
In this study, the investigators hypothesize that administration of coenzyme Q10, as a targeted antioxidant therapy, will ameliorate the excessive oxidative stress experienced by hemodialysis patients. This will lead to improvements in biomarkers of:
- oxidative stress status
- inflammatory status
- endothelial dysfunction
Read the detailed description
There are more than 400,000 patients receiving dialysis in the United States, and the investigators expect that this number will go up. For those on hemodialysis, cardiovascular disease (CVD) accounts for a large part of the health problems that these patients have. Cardiovascular problems come from damage to the heart or blood vessels.
At present, the investigators have no treatments proven to help prevent CVD in those on dialysis. For the general population, the investigators know about many factors that increase the risk of CVD, such as having a high level of "bad" cholesterol. But for people on dialysis, the investigators believe that there are other risk factors that are just as important in the development of CVD.
People on dialysis often have high blood levels of waste products. This is called "uremia". The investigators believe that uremia can set up chemical reactions in the blood which can lead to hardening of the arteries (atherosclerosis), an important part of CVD. Compounds called antioxidants, which stop the chemical reactions, may help prevent CVD.
Coenzyme Q10 is a naturally occurring compound in blood and tissues. It is also a readily available dietary supplement often used as an alternative to other medicines. It is a strong antioxidant. The investigators already know that blood levels of coenzyme Q10 are lower in hemodialysis patients. Because of this, it is important for us to find out if giving coenzyme Q10 to hemodialysis patients can help prevent CVD.
In addition, many people take medications called "statins" to help reduce risk for cardiovascular disease. The investigators know that statins can lower coenzyme Q10. It is important for us to know if hemodialysis patients taking statins have lower levels of coenzyme Q10. It may be that taking coenzyme Q10 could increase the good effects of statin medication in hemodialysis patients.
This study will not last long enough for us to look at the development of CVD in subjects. But the investigators will be able to look at biomarkers of oxidative stress, systemic inflammation, and endothelial function. The investigators know that these biomarkers tell us about uremia and other harmful chemical reactions in the blood. If coenzyme Q10 improves the biomarkers, then the investigators believe that it will also help prevent CVD in hemodialysis patients. Our goal is for improvements in cardiovascular risk for those on hemodialysis.
- Conditions
- Oxidative Stress, Inflammation, Endothelial Dysfunction
- Being tested
- Coenzyme Q10, Placebo
- Keywords
- End-stage Renal Disease, Hemodialysis, Cardiovascular Disease, Antioxidants, Atherosclerosis, Coenzyme Q10
- Medical subject headings
- Inflammation, Kidney Failure, Chronic, Cardiovascular Diseases, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme Q10Dietary supplement
Also called CoQ10
Wafer taken daily by mouth for duration of study, containing Coenzyme Q10 at 600 mg.
Coenzyme Q10Dietary supplement
Also called CoQ10
Wafer taken daily by mouth for duration of study, containing Coenzyme Q10 at 1200 mg.
PlaceboDietary supplement
Wafer taken daily by mouth for duration of study, containing inactive ingredients. Wafer is indistinguishable from those wafers containing CoQ10.
| Study group | Role | What they receive |
|---|---|---|
| Coenzyme Q10 600 mg | Active comparator | Not described Receives: Dietary Supplement: Coenzyme Q10 |
| Coenzyme Q10 1200 mg | Active comparator | Not described Receives: Dietary Supplement: Coenzyme Q10 |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Oxidative Stress Status at 1 month
We will examine whether administration of coenzyme Q10 will ameliorate the excessive oxidative stress burden as evidenced by changes in serum biomarkers of oxidative stress at the 1-month visit.
Measured: 1 month
Change from Baseline in Oxidative Stress Status at 2 months
We will examine whether administration of coenzyme Q10 will ameliorate the excessive oxidative stress burden as evidenced by changes in serum biomarkers of oxidative stress at the 2-month visit.
Measured: 2 months
Change from Baseline in Oxidative Stress Status at 4 months
We will examine whether administration of coenzyme Q10 will ameliorate the excessive oxidative stress burden as evidenced by changes in serum biomarkers of oxidative stress at the 4-month visit.
Measured: 4 months
Secondary outcomes (6)
Change from Baseline in Inflammatory Status at 1 month
We will examine whether administration of coenzyme Q10 will have an effect on inflammation as evidenced by changes in serum biomarkers of inflammatory status at the 1-month visit.
Measured: 1 month
Change from Baseline in Inflammatory Status at 2 months
We will examine whether administration of coenzyme Q10 will have an effect on inflammation as evidenced by changes in serum biomarkers of inflammatory status at the 2-month visit.
Measured: 2 months
Change from Baseline in Inflammatory Status at 4 months
We will examine whether administration of coenzyme Q10 will have an effect on inflammation as evidenced by changes in serum biomarkers of inflammatory status at the 4-month visit.
Measured: 4 months
Change from Baseline in Endothelial Function at 1 month
We will examine whether administration of coenzyme Q10 will have an effect on endothelial function as evidenced by changes in serum biomarkers and Pulse Amplitude Tonometry scores at the 1-month visit.
Measured: 1 month
Change from Baseline in Endothelial Function at 2 months
We will examine whether administration of coenzyme Q10 will have an effect on endothelial function as evidenced by changes in serum biomarkers and Pulse Amplitude Tonometry scores at the 2-month visit.
Measured: 2 months
Change from Baseline in Endothelial Function at 4 months
We will examine whether administration of coenzyme Q10 will have an effect on endothelial function as evidenced by changes in serum biomarkers and Pulse Amplitude Tonometry scores at the 4-month visit.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2011 (estimated)
- Study startNov 2011
- Primary completionOct 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Jonathan Himmelfarb, University of Washington
- Investigators
- Jonathan Himmelfarb, MD, Principal investigator, University of Washington, Kidney Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01408680
- Sponsor's protocol ID
- 40428-A
- Other IDs
- R21AT004265
- Status last verified
- Dec 2014
- First submitted
- 25 Jul 2011
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.
PubMed 37916745
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effect of the Dietary Supplement Coenzyme Q10 on Biomarkers of Oxidative Stress, Systemic Inflammation, and Endothelial Function in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT01408680
- Acronym / sponsor ID
- 40428-A
- Conditions
- Oxidative Stress, Inflammation, Endothelial Dysfunction
- Keywords
- End-stage Renal Disease, Hemodialysis, Cardiovascular Disease, Antioxidants, Atherosclerosis, Coenzyme Q10
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Nov 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 3 Aug 2011 (estimated)
- 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.
The investigators believe that relieving the oxidative stress experienced by hemodialysis patients may help improve cardiovascular health.
In this study, the investigators hypothesize that administration of coenzyme Q10, as a targeted antioxidant therapy, will ameliorate the excessive oxidative stress experienced by hemodialysis patients. This will lead to improvements in biomarkers of:
- oxidative stress status
- inflammatory status
- endothelial dysfunction
Detailed description
There are more than 400,000 patients receiving dialysis in the United States, and the investigators expect that this number will go up. For those on hemodialysis, cardiovascular disease (CVD) accounts for a large part of the health problems that these patients have. Cardiovascular problems come from damage to the heart or blood vessels.
At present, the investigators have no treatments proven to help prevent CVD in those on dialysis. For the general population, the investigators know about many factors that increase the risk of CVD, such as having a high level of "bad" cholesterol. But for people on dialysis, the investigators believe that there are other risk factors that are just as important in the development of CVD.
People on dialysis often have high blood levels of waste products. This is called "uremia". The investigators believe that uremia can set up chemical reactions in the blood which can lead to hardening of the arteries (atherosclerosis), an important part of CVD. Compounds called antioxidants, which stop the chemical reactions, may help prevent CVD.
Coenzyme Q10 is a naturally occurring compound in blood and tissues. It is also a readily available dietary supplement often used as an alternative to other medicines. It is a strong antioxidant. The investigators already know that blood levels of coenzyme Q10 are lower in hemodialysis patients. Because of this, it is important for us to find out if giving coenzyme Q10 to hemodialysis patients can help prevent CVD.
In addition, many people take medications called "statins" to help reduce risk for cardiovascular disease. The investigators know that statins can lower coenzyme Q10. It is important for us to know if hemodialysis patients taking statins have lower levels of coenzyme Q10. It may be that taking coenzyme Q10 could increase the good effects of statin medication in hemodialysis patients.
This study will not last long enough for us to look at the development of CVD in subjects. But the investigators will be able to look at biomarkers of oxidative stress, systemic inflammation, and endothelial function. The investigators know that these biomarkers tell us about uremia and other harmful chemical reactions in the blood. If coenzyme Q10 improves the biomarkers, then the investigators believe that it will also help prevent CVD in hemodialysis patients. Our goal is for improvements in cardiovascular risk for those on hemodialysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Coenzyme Q10 600 mg | Active comparator | Dietary Supplement: Coenzyme Q10 |
| Coenzyme Q10 1200 mg | Active comparator | Dietary Supplement: Coenzyme Q10 |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with end-stage renal disease receiving thrice weekly hemodialysis
- Age ≥ 18 or ≤ 85 years
- Life expectancy greater than one year
- Ability to understand and provide informed consent for participation in the study
Key exclusion criteria (13 listed)
- History of poor adherence to hemodialysis or medical regimen
- Prisoners, patients with significant mental illness, and other vulnerable populations
- AIDS (HIV seropositivity is not an exclusion criteria)
- Active malignancy excluding basal cell carcinoma of the skin
- Gastrointestinal dysfunction requiring parenteral nutrition
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 |
|---|---|---|
| Coenzyme Q10Also: CoQ10Wafer taken daily by mouth for duration of study, containing Coenzyme Q10 at 600 mg. | Dietary supplement | Coenzyme Q10 600 mg |
| Coenzyme Q10Also: CoQ10Wafer taken daily by mouth for duration of study, containing Coenzyme Q10 at 1200 mg. | Dietary supplement | Coenzyme Q10 1200 mg |
| PlaceboWafer taken daily by mouth for duration of study, containing inactive ingredients. Wafer is indistinguishable from those wafers containing CoQ10. | Dietary supplement | Placebo |
Primary outcome
Change from Baseline in Oxidative Stress Status at 1 month
Time frame: 1 month
We will examine whether administration of coenzyme Q10 will ameliorate the excessive oxidative stress burden as evidenced by changes in serum biomarkers of oxidative stress at the 1-month visit.
Change from Baseline in Oxidative Stress Status at 2 months
Time frame: 2 months
We will examine whether administration of coenzyme Q10 will ameliorate the excessive oxidative stress burden as evidenced by changes in serum biomarkers of oxidative stress at the 2-month visit.
Change from Baseline in Oxidative Stress Status at 4 months
Time frame: 4 months
We will examine whether administration of coenzyme Q10 will ameliorate the excessive oxidative stress burden as evidenced by changes in serum biomarkers of oxidative stress at the 4-month visit.
6 secondary outcomes
Change from Baseline in Inflammatory Status at 1 month
Time frame: 1 month
Change from Baseline in Inflammatory Status at 2 months
Time frame: 2 months
Change from Baseline in Inflammatory Status at 4 months
Time frame: 4 months
Change from Baseline in Endothelial Function at 1 month
Time frame: 1 month
Change from Baseline in Endothelial Function at 2 months
Time frame: 2 months
Change from Baseline in Endothelial Function at 4 months
Time frame: 4 months
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 4 Dec 2014.
- Derived from this study: PubMed 37916745Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.
- The mission of Northwest Kidney Centers is to promote the optimal health, quality of life and independence of people with kidney disease, through patient care, education and research.Link provided by the sponsor.
- The Kidney Research Institute is a collaboration between Northwest Kidney Centers and UW Medicine focused on developing early detection, prevention and treatment of kidney disease and its complications.Link provided by the sponsor.
Related trials for Oxidative Stress
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
Not yet recruiting
The Effects of Manual Acupuncture on Superoxide Dismutase Enzyme Activity and Questionnaire of Smoking Urges-Brief Scores in Active Smokers: A Randomized Controlled Trial
Superoxide Dismutase, Acupuncture
Not yet recruiting
Efficacy of MAGNESIO TOTAL on Sleep Quality and Quality of Life in Adults
Sleep Quality, Magnesium Deficiency
RecruitingPhase 2
Combination of NMDA-enhancing and Antioxidant Treatments for Schizophrenia
Schizophrenia
Recruiting
Acute Cryotherapy on Musculoskeletal Function and Biomarkers
Exercise Induced Muscle Damage, Cryotherapy
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.
Jonathan Himmelfarb, MD principal investigator
University of Washington, Kidney Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coenzyme Q10 in people with Oxidative Stress and Inflammation, run by University of Washington at 1 site in United States.
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 4 inclusion and 13 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 4 Dec 2014. 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 United States. 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?
Change from Baseline in Oxidative Stress Status at 1 month (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01408680, which also lists 1 linked publication.
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 4 Dec 2014.