The Safety and Efficacy of a Compound Natural Health Product in Children With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      The study is a randomized control, double blinded trial. A population of 30 children
      diagnosed with ADHD (n=30) will be randomly assigned to the NHP group (n=15) or a placebo
      group (n=15). The NHP group 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. The placebo group will be administered a
      chewable placebo tablet and will follow the same regimen. 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.
    

Intervention name(s): Compound Natural Health Product; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 15-35 mg zinc citrate
150-350 mg magnesium lactate
30-70 mg pyridoxine hydrochloride
150-350 mg calcium ascorbate
Doses are weight based. Chewable tablets are taken 2 times/day with food for the duration of the study; Placebo
Other intervention name(s): Zinc; Magnesium; Vitamin B6; Vitamin C
Intervention MeSH terms: Vitamins; Vitamin B 6
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Attention Deficit Disorder; Pediatrics; Attention; Impulsivity; Complementary Therapies