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Efficacy of Combined Treatment With CoQ10 and Methylphenidate in Children With Attention Deficit Hyperactivity Disorder

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ClinicalTrials.gov Identifier: NCT02315651
Recruitment Status : Unknown
Verified October 2014 by Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 12, 2014
Last Update Posted : December 12, 2014
Sponsor:
Collaborator:
Hebrew University of Jerusalem
Information provided by (Responsible Party):
Rabin Medical Center

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Dietary Supplement: Coenzyme Q10 Dietary Supplement: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Efficacy of Combined Treatment With Co-enzyme Q10 and Methylphenidate in Children With Attention Deficit Hyperactivity Disorder
Study Start Date : January 2015
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : November 2016


Arm Intervention/treatment
Experimental: Coenzyme Q10
30 children aged 6-12 will consume daily a snack containing 60 mg of CoQ10 for 8 weeks.
Dietary Supplement: Coenzyme Q10
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.

Placebo Comparator: Placebo
30 children aged 6-12 years will consume an identical snack without CoQ10 for 8 weeks
Dietary Supplement: Placebo
A snack identical to the trial snack, but without Coenzyme Q10. The snack contains also dried fruits and nuts.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Evaluation of an effect of coenzyme Q10 on nutritional behavior of methylphenidate- treated ADHD children [ Time Frame: 60 days ]
    The evaluation will be executed with 24-h recall and measuring of BMI



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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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 -

Exclusion Criteria:

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

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315651


Contacts
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Contact: Rachel Straussberg, Prof. 972-504399510 rachels2@clalit.org

Locations
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Israel
Schneider children's medical center of Israel
Petach-Tikva, Israel
Sponsors and Collaborators
Rabin Medical Center
Hebrew University of Jerusalem
Investigators
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Principal Investigator: Rachel Straussberg, Prof. Schneider children's medical center of Israe

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Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02315651     History of Changes
Other Study ID Numbers: 7636
First Posted: December 12, 2014    Key Record Dates
Last Update Posted: December 12, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
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Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
Ubiquinone
Coenzyme Q10
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Micronutrients
Nutrients
Growth Substances
Vitamins