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Phase 3 Study of a Compound Natural Health Product in Children With 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.
Details
| Lead sponsor | The Canadian College of Naturopathic Medicine |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 16 |
| Start date | 2013-11 |
| Completion | 2015-11 |
Conditions
- Attention Deficit Hyperactivity Disorder
Interventions
- Compound Natural Health Product
- Placebo
Primary outcomes
- Connors-3 Parent Rating Scale — Baseline, week 5, week 10 and follow-up at week 20
Countries
Canada