HemodialysisNCT05170893
Efficacy and Safety of Coenzyme Q10 in Pediatric Hemodialysis Patients
A study testing Coenzyme Q10 in people with Hemodialysis, run by Ain Shams University at 1 site in Egypt.
Trial summary
All chronic kidney disease patients, whether on regular hemodialysis or not, are at high risk of cardiovascular diseases. This is mainly due to increased oxidative stress, reduced antioxidants and generalized inflammation. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Hemodialysis
- 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
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Jan 2022to 26 Jul 2022
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male or female patients with ages between 2 to 18 years old.
- Undergoing regular hemodialysis for at least 6 months.
Who cannot join
- Patients who weigh less than 10 kg.
Trial locations and contacts
1 site in 1 country.
About this study
All chronic kidney disease patients, whether on regular hemodialysis or not, are at high risk of cardiovascular diseases. This is mainly due to increased oxidative stress, reduced antioxidants and generalized inflammation. Coenzyme Q10 is a vitamin-like antioxidant synthesized in almost all body cells, and it is also available in many dietary sources. It was observed that chronic kidney disease patients have low plasma levels of Coenzyme Q10. Clinical benefits of Coenzyme Q10 supplementation have been documented for various cardiovascular and neurodegenerative disorders. The investigators believe that Coenzyme Q10 supplementation may have potential benefits in pediatric patients receiving hemodialysis; mainly due to its antioxidant activity and anti-inflammatory effects.
- Conditions
- Hemodialysis
- Being tested
- Coenzyme Q10, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme Q10Dietary supplement
Also called ubiquinone, ubidecarenone, ubiquitous quinone
Oral capsules
PlaceboOther
Oral capsules
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Oral Coenzyme Q10 capsules daily for 12 weeks. Receives: Dietary Supplement: Coenzyme Q10 |
| Control group | Placebo comparator | Oral capsules similar to the intervention daily for 12 weeks. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Malondialdehyde (MDA)
marker of oxidative stress
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start17 Jan 2022
- Primary completion14 Jul 2022
- Study completion26 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma AbdelRahman, Misr International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170893
- Sponsor's protocol ID
- ACUC-FP-ASU RHDIRB2020110301
- Status last verified
- Jul 2023
- First submitted
- 11 Dec 2021
- Last updated
- 19 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Coenzyme Q10 in Pediatric Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT05170893
- Acronym / sponsor ID
- ACUC-FP-ASU RHDIRB2020110301
- Conditions
- Hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 14 Jul 2022 (actual)
- Study completion
- 26 Jul 2022 (actual)
- First posted
- 28 Dec 2021 (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.
All chronic kidney disease patients, whether on regular hemodialysis or not, are at high risk of cardiovascular diseases. This is mainly due to increased oxidative stress, reduced antioxidants and generalized inflammation. Coenzyme Q10 is a vitamin-like antioxidant synthesized in almost all body cells, and it is also available in many dietary sources. It was observed that chronic kidney disease patients have low plasma levels of Coenzyme Q10. Clinical benefits of Coenzyme Q10 supplementation have been documented for various cardiovascular and neurodegenerative disorders. The investigators believe that Coenzyme Q10 supplementation may have potential benefits in pediatric patients receiving hemodialysis; mainly due to its antioxidant activity and anti-inflammatory effects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: Coenzyme Q10Oral Coenzyme Q10 capsules daily for 12 weeks. |
| Control group | Placebo comparator | Other: PlaceboOral capsules similar to the intervention daily for 12 weeks. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Male or female patients with ages between 2 to 18 years old.
- Undergoing regular hemodialysis for at least 6 months.
Key exclusion criteria (1 listed)
- Patients who weigh less than 10 kg.
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: ubiquinone, ubidecarenone, ubiquitous quinoneOral capsules | Dietary supplement | Intervention group |
| PlaceboOral capsules | Other | Control group |
Primary outcome
Change in Malondialdehyde (MDA)
Time frame: 12 weeks
marker of oxidative stress
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 19 Jul 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hemodialysis, run by Ain Shams University at 1 site in Egypt.
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 2 inclusion and 1 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 19 Jul 2023. 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 Egypt. 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 in Malondialdehyde (MDA) (time frame: 12 weeks). 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 19 Jul 2023.