The Safety and Efficacy of a Compound Natural Health Product in Children With Attention Deficit Hyperactivity Disorder (ADHD)
The purpose of this study is to investigate the use of a natural health product, as compared to placebo (an inactive substance), in managing the symptoms of ADHD. The natural health product contains the nutrients zinc, magnesium, vitamin B6 and vitamin C. Each of these nutrients has some evidence to suggest that children with ADHD might be lacking them. As such, children with ADHD might benefit from supplementing their diets with these nutrients, especially ADHD children who have below average levels.
This study will measure whether the severity of ADHD symptoms is greater in children with low levels of zinc, magnesium, and vitamin B6, and whether the severity of ADHD symptoms will decrease with supplementation of these nutrients. This study will also monitor for any adverse reactions or side effects from taking these nutrients in children.
Although these natural health products are commercially available, the use of them as a supplement or placebo in this study has been approved for use in this study by the Natural Health Products Directorate of Health Canada.
|Attention Deficit Hyperactivity Disorder||Dietary Supplement: Compound Natural Health Product Dietary Supplement: Placebo||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||Phase 3 Study of a Compound Natural Health Product in Children With ADHD|
- Connors-3 Parent Rating Scale [ Time Frame: Baseline, week 5, week 10 and follow-up at week 20 ]
- Nutritional status of zinc and magnesium [ Time Frame: Week 0 and week 10 ]
- Adverse events [ Time Frame: Throughout study ]
- SNAP-IV Parent ADHD questionnaire [ Time Frame: Week 0, week 5 and week 10 ]
|Study Start Date:||November 2013|
|Study Completion Date:||November 2015|
|Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Experimental: Compound Natural Health Product
15 study participants who will receive the compound natural health product.
Dietary Supplement: Compound Natural Health Product
Doses are weight based. Chewable tablets are taken 2 times/day with food for the duration of the study
Placebo Comparator: Placebo
15 participants will receive placebo natural health product.
Dietary Supplement: Placebo
Please refer to this study by its ClinicalTrials.gov identifier: NCT01022229
|Robert Schad Naturopathic Clinic|
|Toronto, Ontario, Canada, M2K 1E2|
|Study Director:||Umesh Jain, MD||The Centre for Addiction and Mental Health|