deltatrials
Completed PHASE2/PHASE3 INTERVENTIONAL 1-arm NCT00704990

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

Updated 6 times since 2017 Last updated: Oct 15, 2015 Started: Sep 30, 2008 Primary completion: Dec 31, 2009 Completion: Dec 31, 2009
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

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 Once enrolled, children can withdraw from the study at any time if assent to participate is withdrawn.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

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

6 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE2/PHASE3

  2. Sep 2024 — Present [monthly]

    Completed PHASE2/PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2/PHASE3

    Phase: PHASE2_PHASE3PHASE2/PHASE3

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE2_PHASE3

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE2_PHASE3

Show 1 earlier version
  1. 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

Sponsor contact:
  • Centre for Addiction and Mental Health
  • Kieran Cooley
  • The Canadian College of Naturopathic Medicine
  • University of Toronto
Data source: The Canadian College of Naturopathic Medicine

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations