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

NCT01022229 | Completed Phase 3 DMC

• 1 other identifier: CCNM-0903
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Attention Deficit Disorder; Pediatrics; Attention; Impulsivity; Complementary Therapies

Outcome Measures

Primary Outcomes (1)

• Connors-3 Parent Rating Scale

  Baseline, week 5, week 10 and follow-up at week 20

Secondary Outcomes (3)

• Nutritional status of zinc and magnesium

  Week 0 and week 10

• Adverse events

  Throughout study

• SNAP-IV Parent ADHD questionnaire

  Week 0, week 5 and week 10

Study Arms (2)

Compound Natural Health Product

EXPERIMENTAL

15 study participants who will receive the compound natural health product.

Dietary Supplement: Compound Natural Health Product

Placebo

PLACEBO COMPARATOR

15 participants will receive placebo natural health product.

Dietary Supplement: Placebo

Interventions

Compound Natural Health Product DIETARY_SUPPLEMENT

* 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

Also known as: Zinc, Magnesium, Vitamin B6, Vitamin C

Compound Natural Health Product

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male and female children age 6-12 diagnosed with ADHD of any subtype according to DSM-IV criteria. A structured diagnostic interview (Kiddie Sads Present and Lifetime Version) will be conducted to confirm diagnosis of ADHD and assess for comorbid mental health disorders
• Primary caregiver (parent or guardian) has given informed consent; child participant gives ongoing assent throughout the study.

You may not qualify if:

• Changes to participants' ADHD medication within 6 weeks of study onset.
• Diagnosis of additional mental health disorder using the Kiddie Sads.
• Diagnosis of cancer.
• Antibiotic use for periods greater than 2 weeks within the 10 weeks prior to the study
• Diagnosis of Type 1 diabetes and insulin use
• Low serum ferritin/iron deficiency (\<30 ng/ml)

Sponsors & Collaborators

• The Canadian College of Naturopathic Medicine: lead
• Health Canada: collaborator
• Centre for Addiction and Mental Health: collaborator
• SickKids Foundation: collaborator

Study Sites (1)

Robert Schad Naturopathic Clinic

Toronto, Ontario, M2K 1E2, Canada

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Impulsive Behavior

Interventions

Zinc; Magnesium; Vitamin B 6; Ascorbic Acid

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Metals, Alkaline Earth; Metals, Light; Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Umesh Jain, MD

  The Centre for Addiction and Mental Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2009
• First Posted: December 1, 2009
• Study Start: November 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 28, 2016

Record last verified: 2016-01

Locations

CA (1)