Clinical trial NCT00704990: Combination Natural Health Product in Children With Attention Deficit/Hyperactivity Disorder (ADHD)
Official title: The Safety and Efficacy of a Compound Natural Health Product in Children With Attention Deficit/Hyperactivity Disorder: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Attention Deficit Disorder
Pediatrics
Attention
Impulsivity
Complementary Therapies
Lead sponsor: The Canadian College of Naturopathic Medicine
Sponsor class: OTHER
Collaborators: name: The Canadian College of Naturopathic Medicine
name: University of Toronto
name: Centre for Addiction and Mental Health
First posted: 2008-06-25
Enrollment: 28
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Attention deficit/hyperactivity disorder (ADHD) is a chronic neurobehavioural disorder often diagnosed in childhood years. Complementary/alternative treatments including natural health products (NHPs) are used by children with ADHD despite limited information on their safety or usefulness. Some evidence suggests children with ADHD have a greater need for zinc, magnesium, vitamin B6 and vitamin C. This study will supplement a small number of children diagnosed with ADHD with therapeutic levels of these nutrients over 10 weeks to get a better understanding of the safety and possible benefit of using these nutrients to treat symptoms associated with ADHD.

Detailed description: The is an open-label study. Children diagnosed with ADHD will be provided with a weight-based dose of a chewable natural health product containing zinc, magnesium, vitamin B6 and vitamin C for 10 weeks with an additional follow-up post intervention at 20 weeks. Severity of ADHD symptoms will be measured at baseline, week 5 and week 10 using the Connor-3 Parent and SNAP-IV validated questionnaires. Nutritional status will be monitored at baseline and week 10 for changes in serum zinc and erythrocyte magnesium. Children will be monitored for any adverse reactions that may occur using the investigational product.Following the informed consent process, participants will undergo a structured psychiatric interview prior to enrollment and will have 4 30 minute study visits and 2 10 minute telephone calls throughout the study. Blood samples will be taken 2 times with the use of a topical anesthetic to decrease sensation during the blood draw. Once enrolled, children can withdraw from the study at any time if assent to participate is withdrawn.

Eligibility criteria: Inclusion Criteria:

* Male and female children age 6-12 diagnosed with ADHD of any subtype according to DSM-IV criteria. A structured diagnostic interview (Kiddie Sads Present and Lifetime Version) will be conducted to confirm diagnosis of ADHD and assess for comorbid mental health disorders.
* Primary caregiver (parent or guardian) has given informed consent; child participant gives ongoing assent throughout the study.

Exclusion Criteria:

* Changes to participants' ADHD medication within 6 weeks of study onset.
* Diagnosis of additional mental health disorder using the Kiddie Sads.
* Diagnosis of cancer.
* Antibiotic use for periods greater than 2 weeks within the 10 weeks prior to the study
* Diagnosis of Type 1 diabetes and insulin use
* Low serum ferritin/iron deficiency (\<30 ng/ml)

Primary outcomes:
measure: Connors-3 Parent Rating Scale
timeFrame: Baseline, week 5, week 10 and follow-up at week 20
Secondary outcomes:
measure: Nutritional status of zinc and magnesium
timeFrame: Week 0 and week 10
measure: Adverse events
timeFrame: Throughout study
measure: SNAP-IV Parent ADHD questionnaire
timeFrame: Week 0, week 5 and week 10
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Robert Schad Naturopathic Clinic
state: Ontario
city: Toronto
country: Canada
facility: The Center for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: University of Toronto
name: Heather Boon, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Center for Addiction and Mental Health
name: Umesh Jain, MD
role: STUDY_DIRECTOR
References: