Status:
COMPLETED
Combination Natural Health Product in Children With Attention Deficit/Hyperactivity Disorder (ADHD)
Lead Sponsor:
Kieran Cooley
Collaborating Sponsors:
The Canadian College of Naturopathic Medicine
University of Toronto
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
6-12 years
Phase:
PHASE2
PHASE3
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)...
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 week...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00704990
Start Date
September 1 2008
End Date
December 1 2009
Last Update
October 19 2015
Active Locations (2)
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1
Robert Schad Naturopathic Clinic
Toronto, Ontario, Canada, M2K 1E2
2
The Center for Addiction and Mental Health
Toronto, Ontario, Canada, M5T 2S1