Attention Deficit Hyperactivity DisorderNCT02315651
Efficacy of Combined Treatment With CoQ10 and Methylphenidate in Children With Attention Deficit Hyperactivity Disorder
A study testing Coenzyme Q10 in people with Attention Deficit Hyperactivity Disorder, run by Rabin Medical Center at 1 site in Israel.
Trial summary
The aim of this study is to evaluate the effects of nutritional supplement co-enzyme Q10 (CoQ10) on methylphenidate-treated ADHD children in a randomized, double-blinded, placebo-controlled prospective study. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Coenzyme Q10
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2015to Nov 2016
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 6-12. Diagnosed as ADHD according to DSM4 At least 3 months treated with methylphenidate Informed consent of a parent and agreement of a teacher for participation in the trial -
Who cannot join
- Adolescent girls after more than 3 menses History or current diagnosis of systemic diseases, diabetes, thyroid abnormalities or problems with neural system, such as epilepsy or brain tumor.
- Children with other psychiatric disorders, as diagnosed according to DSM4. Children with a risk to suicide. Using of psychiatric medications other then methylphenidate. Using of dietary supplements at least 4 weeks before enrollment. History of abuse of alcohol or drugs according to DSM4. Consuming of above 250 mg of caffeine. Allergy for one of the snack's ingredients. Use of drugs for chronic diseases
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Combined Treatment With Co-enzyme Q10 and Methylphenidate in Children With Attention Deficit Hyperactivity Disorder
The aim of this study is to evaluate the effects of nutritional supplement co-enzyme Q10 (CoQ10) on methylphenidate-treated ADHD children in a randomized, double-blinded, placebo-controlled prospective study. All eligible patients will undergo randomization and divided into 2 groups: a CoQ10-enriched snack and a placebo snack group. According to power calculation, total of 60 subjects are expected to participate in the study. After the screening of eligibility (up to 14 days), the study is divided into three phases: pre-treatment (first assessment) phase (up to 14 days), treatment phase 8 weeks of treatment, and post-treatment phase. Screening: each participant will undergo screening for protocol eligibility within 14 days (two weeks) of recruitment. Subjects who meet all the inclusion criteria and signed an approved informed consent (both parents and the child) will be enrolled.
Read the detailed description
The aim of this study is to evaluate the effects of nutritional supplement co-enzyme Q10 (CoQ10) on methylphenidate-treated ADHD children in a randomized, double-blinded, placebo-controlled prospective study. All eligible patients will undergo randomization and divided into 2 groups: a CoQ10-enriched snack and a placebo snack group. According to power calculation, total of 60 subjects are expected to participate in the study. After the screening of eligibility (up to 14 days), the study is divided into three phases: pre-treatment (first assessment) phase (up to 14 days), treatment phase 8 weeks of treatment, and post-treatment phase. Screening: each participant will undergo screening for protocol eligibility within 14 days (two weeks) of recruitment. Subjects who meet all the inclusion criteria and signed an approved informed consent (both parents and the child) will be enrolled.
Pre-treatment period (1-st phase): for the purpose of the first assessment, participants' parents will receive Conner's questionnaire for filling by parents and teachers. The first nutritional assessment will be undertaken using 24-h recall assessment.
Treatment period (2-st phase): randomization and treatment. After randomization to 2 groups, CoQ10 and placebo groups, the participants' parents will receive either CoQ10-enriched or placebo snack for 8 weeks (2 months) period. The participants and their parents will be instructed to consume the snack daily. During the study the subjects will manage with their methylphenidate treatment as indicated by their neurologist.
Post-treatment assessment (3-rd phase): At the end of the study period, an additional assessment identical to this of the pre-treatment will be taken to evaluate subjects' response to the snacks.
Statistical analysis (4-th phase): At the end of the study, statistical analysis will be undertaken. Statistical difference between two groups in their pre-treatment and post-treatment behavioral and nutritional response will serve as an evidence for the efficacy of the supplement being used. All data will be documented in patient charts and individual computerized case report form .
The duration of the study is expected to be 2 years.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Coenzyme Q10, Placebo
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme Q10Dietary supplement
A snack containing 60 mg of Coenzyme Q10. The snack contains also dried fruits and nuts, and their content are identical to this of placebo.
PlaceboDietary supplement
A snack identical to the trial snack, but without Coenzyme Q10. The snack contains also dried fruits and nuts.
| Study group | Role | What they receive |
|---|---|---|
| Coenzyme Q10 | Experimental | 30 children aged 6-12 will consume daily a snack containing 60 mg of CoQ10 for 8 weeks. Receives: Dietary Supplement: Coenzyme Q10 |
| Placebo | Placebo comparator | 30 children aged 6-12 years will consume an identical snack without CoQ10 for 8 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of an effect of coenzyme CoQ10 on behavioral aspects of methylphenidate- treated ADHD children
The evaluation will be executed with Conners score
Measured: 60 days
Secondary outcomes (1)
Evaluation of an effect of coenzyme Q10 on nutritional behavior of methylphenidate- treated ADHD children
The evaluation will be executed with 24-h recall and measuring of BMI
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionNov 2015 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies 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, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Hebrew University of Jerusalem
- Responsible party
- Sponsor
- Investigators
- Rachel Straussberg, Prof., Principal investigator, Schneider children's medical center of Israe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02315651
- Sponsor's protocol ID
- 7636
- Status last verified
- Oct 2014
- First submitted
- 3 Nov 2014
- Last updated
- 12 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Combined Treatment With Co-enzyme Q10 and Methylphenidate in Children With Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT02315651
- Acronym / sponsor ID
- 7636
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- Hebrew University of Jerusalem
- Study start
- Jan 2015
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 12 Dec 2014 (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 aim of this study is to evaluate the effects of nutritional supplement co-enzyme Q10 (CoQ10) on methylphenidate-treated ADHD children in a randomized, double-blinded, placebo-controlled prospective study. All eligible patients will undergo randomization and divided into 2 groups: a CoQ10-enriched snack and a placebo snack group. According to power calculation, total of 60 subjects are expected to participate in the study. After the screening of eligibility (up to 14 days), the study is divided into three phases: pre-treatment (first assessment) phase (up to 14 days), treatment phase 8 weeks of treatment, and post-treatment phase. Screening: each participant will undergo screening for protocol eligibility within 14 days (two weeks) of recruitment. Subjects who meet all the inclusion criteria and signed an approved informed consent (both parents and the child) will be enrolled.
Detailed description
The aim of this study is to evaluate the effects of nutritional supplement co-enzyme Q10 (CoQ10) on methylphenidate-treated ADHD children in a randomized, double-blinded, placebo-controlled prospective study. All eligible patients will undergo randomization and divided into 2 groups: a CoQ10-enriched snack and a placebo snack group. According to power calculation, total of 60 subjects are expected to participate in the study. After the screening of eligibility (up to 14 days), the study is divided into three phases: pre-treatment (first assessment) phase (up to 14 days), treatment phase 8 weeks of treatment, and post-treatment phase. Screening: each participant will undergo screening for protocol eligibility within 14 days (two weeks) of recruitment. Subjects who meet all the inclusion criteria and signed an approved informed consent (both parents and the child) will be enrolled.
Pre-treatment period (1-st phase): for the purpose of the first assessment, participants' parents will receive Conner's questionnaire for filling by parents and teachers. The first nutritional assessment will be undertaken using 24-h recall assessment.
Treatment period (2-st phase): randomization and treatment. After randomization to 2 groups, CoQ10 and placebo groups, the participants' parents will receive either CoQ10-enriched or placebo snack for 8 weeks (2 months) period. The participants and their parents will be instructed to consume the snack daily. During the study the subjects will manage with their methylphenidate treatment as indicated by their neurologist.
Post-treatment assessment (3-rd phase): At the end of the study period, an additional assessment identical to this of the pre-treatment will be taken to evaluate subjects' response to the snacks.
Statistical analysis (4-th phase): At the end of the study, statistical analysis will be undertaken. Statistical difference between two groups in their pre-treatment and post-treatment behavioral and nutritional response will serve as an evidence for the efficacy of the supplement being used. All data will be documented in patient charts and individual computerized case report form .
The duration of the study is expected to be 2 years.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coenzyme Q10 | Experimental | Dietary Supplement: Coenzyme Q1030 children aged 6-12 will consume daily a snack containing 60 mg of CoQ10 for 8 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo30 children aged 6-12 years will consume an identical snack without CoQ10 for 8 weeks |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 6-12. Diagnosed as ADHD according to DSM4 At least 3 months treated with methylphenidate Informed consent of a parent and agreement of a teacher for participation in the trial -
Key exclusion criteria (3 listed)
- Adolescent girls after more than 3 menses History or current diagnosis of systemic diseases, diabetes, thyroid abnormalities or problems with neural system, such as epilepsy or brain tumor.
- Children with other psychiatric disorders, as diagnosed according to DSM4. Children with a risk to suicide. Using of psychiatric medications other then methylphenidate. Using of dietary supplements at least 4 weeks before enrollment. History of abuse of alcohol or drugs according to DSM4. Consuming of above 250 mg of caffeine. Allergy for one of the snack's ingredients. Use of drugs for chronic diseases
- -
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 Q10A snack containing 60 mg of Coenzyme Q10. The snack contains also dried fruits and nuts, and their content are identical to this of placebo. | Dietary supplement | Coenzyme Q10 |
| PlaceboA snack identical to the trial snack, but without Coenzyme Q10. The snack contains also dried fruits and nuts. | Dietary supplement | Placebo |
Primary outcome
Evaluation of an effect of coenzyme CoQ10 on behavioral aspects of methylphenidate- treated ADHD children
Time frame: 60 days
The evaluation will be executed with Conners score
1 secondary outcome
Evaluation of an effect of coenzyme Q10 on nutritional behavior of methylphenidate- treated ADHD children
Time frame: 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2014.
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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.
Rachel Straussberg, Prof. principal investigator
Schneider children's medical center of Israe
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 Attention Deficit Hyperactivity Disorder, run by Rabin Medical Center at 1 site in Israel.
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 3 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: status not confirmed, as of the sponsor's last update on 12 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel Straussberg, Prof. (972-504399510, rachels2@clalit.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of an effect of coenzyme CoQ10 on behavioral aspects of methylphenidate- treated ADHD children (time frame: 60 days). 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 12 Dec 2014; AzTrials last refreshed its copy on 8 Nov 2026.