Pediatric Dilated CardiomyopathyNCT02847585
Potential Role of Water-soluble Ubiquinol in Complementary Therapy for Pediatric Dilated Cardiomyopathy
A study testing Water-soluble Ubiquinol in people with Pediatric Dilated Cardiomyopathy, run by Chung Shan Medical University at 1 site in Taiwan.
Trial summary
Pediatric dilated cardiomyopathy (PDCM) is the most common form fond in children. Water-soluble coenzyme Q10 (ubiquinol) is better absorbed than lipid-soluble coenzyme Q10 (ubiquinone) and is directly involved in the antioxidant cycle. Read more about this study
- Who is it for?
- Ages 1 month to 20 years
- Conditions the study is for
- Pediatric Dilated Cardiomyopathy
- What is being tested?
- Water-soluble Ubiquinol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2016to 6 Jul 2018
- 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 1 month to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric dilated cardiomyopathy defined as left ventricular ejection fraction ≤ 40 % by cardiac echo examination.
Who cannot join
- Hypertension
- Arrhythmia
- Congenital heart defects
- Acute myocarditis
- Pregnant and lactating teens
- Antioxidant vitamins users
Trial locations and contacts
1 site in 1 country.
About this study
Pediatric dilated cardiomyopathy (PDCM) is the most common form fond in children. Water-soluble coenzyme Q10 (ubiquinol) is better absorbed than lipid-soluble coenzyme Q10 (ubiquinone) and is directly involved in the antioxidant cycle. Because coenzyme Q10 has shown significant health benefits in adult patients with cardiovascular disease, it is worth studying water-soluble coenzyme Q10 supplements to evaluate their potential role as complementary therapy for PDCM. The purpose of this study is to explore the potential role of water-soluble ubiquinol in complementary therapy for pediatric cardiomyopathy. We will recruit 25 children with primary PDCM (age 0-20 y) and examine the relationship between coenzyme Q10 level and cardiac function (left ventricular fractional shortening and ejection fraction, and B-type natriuretic peptide), oxidative stress (malondialdehyde), antioxidant enzymes activity (catalase, glutathione peroxide, and superoxide dismutase), and inflammation (high sensitivity C-reactive protein and interleukin-6) in PMC after 6 months water-soluble ubiquinol supplementation (10 mg/kg BW/d, by oral drops). In addition, we will assess the quality of life of PDCM patients by questionnaire. Through this study, we expect to demonstrate that water-soluble coenzyme Q10 will be a complementary therapy for PDCM, and will improve cardiac function, increase antioxidant capacity, slow deterioration of cardiac function and reduce inflammation, and further reduce the rate of heart transplantation and increase quality of life in PDCM.
- Conditions
- Pediatric Dilated Cardiomyopathy
- Being tested
- Water-soluble Ubiquinol
- Keywords
- water-soluble ubiquinol supplementation, pediatric cardiomyopathy, antioxidant, inflammation, complementary therapy
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water-soluble UbiquinolDietary supplement
10 mg/kg BW/d, by oral drops
| Study group | Role | What they receive |
|---|---|---|
| Open label | Experimental | water-soluble ubiquinol Receives: Dietary Supplement: Water-soluble Ubiquinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular ejection fraction
Left ventricular ejection fraction (%) will be measured by cardiac echo.
Measured: 6 months
Secondary outcomes (8)
Levels of plasma coenzyme Q10
Plasma coenzyme Q10 (micromol/L) will be measured by high performance liquid chromatography.
Measured: 6 months
B-type natriuretic peptide (BNP)
BNP (pg/mL) will be measured by fluorescence immunoassay.
Measured: 6 months
malondialdehyde (MDA)
MDA (micromol/L) will be measured by thiobarbituric acid reacting substance.
Measured: 6 months
catalase (CAT)
red blood cells level of CAT in unit/mg protein.
Measured: 6 months
glutathione peroxide (GPx)
red blood cells level of GPx in unit/mg protein.
Measured: 6 months
superoxide dismutase (SOD)
red blood cells level of SOD in unit/mg protein.
Measured: 6 months
high sensitivity C-reactive protein (hs-CRP)
hs-CRP (mg/dL) will be measured by Immunoturbidimetry.
Measured: 6 months
high sensitivity interleukin-6 (IL-6)
IL-6 (pg/dL) will be measured by immunosorbent assay.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study start1 Aug 2016
- Primary completion30 May 2018
- Study completion6 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Dilated CardiomyopathyStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeh, Chung Shan Medical University
- Investigators
- Ping-Ting Lin, Ph.D., Principal investigator, School of Nutrition, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02847585
- Sponsor's protocol ID
- MOST105-2628-B-040-MY2
- Status last verified
- Jul 2018
- First submitted
- 12 Jul 2016
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Role of Water-soluble Ubiquinol in Complementary Therapy for Pediatric Dilated Cardiomyopathy
- ClinicalTrials.gov ID
- NCT02847585
- Acronym / sponsor ID
- MOST105-2628-B-040-MY2
- Conditions
- Pediatric Dilated Cardiomyopathy
- Keywords
- water-soluble ubiquinol supplementation, pediatric cardiomyopathy, antioxidant, inflammation, complementary therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 6 Jul 2018 (actual)
- First posted
- 28 Jul 2016 (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.
Pediatric dilated cardiomyopathy (PDCM) is the most common form fond in children. Water-soluble coenzyme Q10 (ubiquinol) is better absorbed than lipid-soluble coenzyme Q10 (ubiquinone) and is directly involved in the antioxidant cycle. Because coenzyme Q10 has shown significant health benefits in adult patients with cardiovascular disease, it is worth studying water-soluble coenzyme Q10 supplements to evaluate their potential role as complementary therapy for PDCM. The purpose of this study is to explore the potential role of water-soluble ubiquinol in complementary therapy for pediatric cardiomyopathy. We will recruit 25 children with primary PDCM (age 0-20 y) and examine the relationship between coenzyme Q10 level and cardiac function (left ventricular fractional shortening and ejection fraction, and B-type natriuretic peptide), oxidative stress (malondialdehyde), antioxidant enzymes activity (catalase, glutathione peroxide, and superoxide dismutase), and inflammation (high sensitivity C-reactive protein and interleukin-6) in PMC after 6 months water-soluble ubiquinol supplementation (10 mg/kg BW/d, by oral drops). In addition, we will assess the quality of life of PDCM patients by questionnaire. Through this study, we expect to demonstrate that water-soluble coenzyme Q10 will be a complementary therapy for PDCM, and will improve cardiac function, increase antioxidant capacity, slow deterioration of cardiac function and reduce inflammation, and further reduce the rate of heart transplantation and increase quality of life in PDCM.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open label | Experimental | Dietary Supplement: Water-soluble Ubiquinolwater-soluble ubiquinol |
Who may qualify
- Ages
- 1 month to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Pediatric dilated cardiomyopathy defined as left ventricular ejection fraction ≤ 40 % by cardiac echo examination.
Key exclusion criteria (6 listed)
- Hypertension
- Arrhythmia
- Congenital heart defects
- Acute myocarditis
- Pregnant and lactating teens
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 |
|---|---|---|
| Water-soluble Ubiquinol10 mg/kg BW/d, by oral drops | Dietary supplement | Open label |
Primary outcome
Left ventricular ejection fraction
Time frame: 6 months
Left ventricular ejection fraction (%) will be measured by cardiac echo.
8 secondary outcomes
Levels of plasma coenzyme Q10
Time frame: 6 months
B-type natriuretic peptide (BNP)
Time frame: 6 months
malondialdehyde (MDA)
Time frame: 6 months
catalase (CAT)
Time frame: 6 months
glutathione peroxide (GPx)
Time frame: 6 months
superoxide dismutase (SOD)
Time frame: 6 months
high sensitivity C-reactive protein (hs-CRP)
Time frame: 6 months
high sensitivity interleukin-6 (IL-6)
Time frame: 6 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 11 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Ping-Ting Lin, Ph.D. principal investigator
School of Nutrition, Chung Shan Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water-soluble Ubiquinol in people with Pediatric Dilated Cardiomyopathy, run by Chung Shan Medical University 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 1 inclusion and 6 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 11 Jul 2018. 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. 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?
Left ventricular ejection fraction (time frame: 6 months). 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 11 Jul 2018.