Combination Natural Health Product in Children With Attention Deficit/Hyperactivity Disorder (ADHD)
The Safety and Efficacy of a Compound Natural Health Product in Children With Attention Deficit/Hyperactivity Disorder: A Pilot Study
Sponsor: Centre for Addiction and Mental Health
Listed as NCT00704990, this PHASE2/PHASE3 trial focuses on Attention Deficit Hyperactivity Disorder and remains completed. Sponsored by Centre for Addiction and Mental Health, it has been updated 6 times since 2008, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)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 weeks with an additional follow-up post intervention at 20 weeks. 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 Once enrolled, children can withdraw from the study at any time if assent to participate is withdrawn.
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 weeks with an additional follow-up post intervention at 20 weeks. 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.
Status Flow
Change History
6 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE2/PHASE3
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Sep 2024 — Present [monthly]
Completed PHASE2/PHASE3
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE2/PHASE3
Phase: PHASE2_PHASE3 → PHASE2/PHASE3
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Jan 2021 — Jul 2024 [monthly]
Completed PHASE2_PHASE3
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE2_PHASE3
▶ Show 1 earlier version
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Jan 2017 — Jun 2018 [monthly]
Completed PHASE2_PHASE3
First recorded
Sep 2008
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Centre for Addiction and Mental Health
- Kieran Cooley
- The Canadian College of Naturopathic Medicine
- University of Toronto
For direct contact, visit the study record on ClinicalTrials.gov .