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Combination Natural Health Product in Children With Attention Deficit/Hyperactivity Disorder (ADHD)

NCT00704990 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2015-10-19

No results posted yet for this study

Summary

Attention deficit/hyperactivity disorder (ADHD) is a chronic neurobehavioural disorder often diagnosed in childhood years. Complementary/alternative treatments including natural health products (NHPs) are used by children with ADHD despite limited information on their safety or usefulness. Some evidence suggests children with ADHD have a greater need for zinc, magnesium, vitamin B6 and vitamin C. This study will supplement a small number of children diagnosed with ADHD with therapeutic levels of these nutrients over 10 weeks to get a better understanding of the safety and possible benefit of using these nutrients to treat symptoms associated with ADHD.

Conditions

  • Attention Deficit Hyperactivity Disorder

Interventions

DIETARY_SUPPLEMENT

Zinc, Magnesium, Vitamin B6, Vitamin C (Compound Natural Health Product for ADHD)

Weight based dosing of a chewable natural health product containing 15-35 mg zinc citrate, 150-350 mg magnesium lactate, 30-70 mg pyridoxine hydrochloride and 150-350 mg calcium ascorbate. Participants will take weight based dose two times during the day with meals for a 10 week period

Sponsors & Collaborators

  • The Canadian College of Naturopathic Medicine

    collaborator OTHER

  • University of Toronto

    collaborator OTHER

  • Centre for Addiction and Mental Health

    collaborator OTHER

  • Kieran Cooley

    lead OTHER

Principal Investigators

  • Heather Boon, PhD · University of Toronto

  • Umesh Jain, MD · The Center for Addiction and Mental Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00704990 on ClinicalTrials.gov