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

NCT01022229 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2016-01-28

No results posted yet for this study

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.

Conditions

  • Attention Deficit Hyperactivity Disorder

Interventions

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

Sponsors & Collaborators

  • Health Canada

    collaborator OTHER_GOV

  • Centre for Addiction and Mental Health

    collaborator OTHER

  • SickKids Foundation

    collaborator OTHER

  • The Canadian College of Naturopathic Medicine

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Canada

Study Locations

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Entities

Companies

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 NCT01022229 on ClinicalTrials.gov