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

NCT02315651 | Unknown

• 1 other identifier: 7636
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• Evaluation of an effect of coenzyme CoQ10 on behavioral aspects of methylphenidate- treated ADHD children

  The evaluation will be executed with Conners score

  60 days

Secondary Outcomes (1)

• Evaluation of an effect of coenzyme Q10 on nutritional behavior of methylphenidate- treated ADHD children

  60 days

Study Arms (2)

Coenzyme Q10

EXPERIMENTAL

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

Dietary Supplement: Coenzyme Q10

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Coenzyme Q10 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.

Coenzyme Q10

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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 -

You may not qualify if:

• 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

Sponsors & Collaborators

• Rabin Medical Center: lead
• Hebrew University of Jerusalem: collaborator

Study Sites (1)

Schneider children's medical center of Israel

Petah Tikva, Israel

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

coenzyme Q10

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Rachel Straussberg, Prof.

  Schneider children's medical center of Israe

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Straussberg, Prof.

CONTACT

972-504399510; rachels2@clalit.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: December 12, 2014
• Study Start: January 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2016
• Last Updated: December 12, 2014

Record last verified: 2014-10

Locations

IL (1)