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

NCT ID: NCT02315651

Last Updated: 2014-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-11-30

Brief Summary

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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

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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

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Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Coenzyme Q10

30 children aged 6-12 will consume daily a snack containing 60 mg of CoQ10 for 8 weeks.

Group Type EXPERIMENTAL

Coenzyme Q10

Intervention Type DIETARY_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.

Placebo

30 children aged 6-12 years will consume an identical snack without CoQ10 for 8 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

A snack identical to the trial snack, but without Coenzyme Q10. The snack contains also dried fruits and nuts.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Placebo

A snack identical to the trial snack, but without Coenzyme Q10. The snack contains also dried fruits and nuts.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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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Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hebrew University of Jerusalem

OTHER

Sponsor Role collaborator

Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rachel Straussberg, Prof.

Role: PRINCIPAL_INVESTIGATOR

Schneider children's medical center of Israe

Locations

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Schneider children's medical center of Israel

Petah Tikva, , Israel

Site Status

Countries

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Israel

Central Contacts

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Rachel Straussberg, Prof.

Role: CONTACT

Phone: 972-504399510

Email: [email protected]

Other Identifiers

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7636

Identifier Type: -

Identifier Source: org_study_id