NCT01022229

The Safety and Efficacy of a Compound Natural Health Product in Children With Attention Deficit Hyperactivity Disorder (ADHD)

Phase 3 Study of a Compound Natural Health Product in Children With ADHD

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: The Canadian College of Naturopathic Medicine · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Compound Natural Health Product	* 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
DIETARY_SUPPLEMENT	Placebo	Placebo

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2009-12-01
• Last updated: 2016-01-28

Locations

1 site across 1 country: Canada