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

NCT00704990 | Completed Phase 2 DMC

• 1 other identifier: CCNM-083-ADHD
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief 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

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 (1)

A

EXPERIMENTAL

All study participants take part in the experimental arm

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

Interventions

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

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

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

A

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

• Kieran Cooley: lead
• The Canadian College of Naturopathic Medicine: collaborator
• University of Toronto: collaborator
• Centre for Addiction and Mental Health: collaborator

Study Sites (2)

Robert Schad Naturopathic Clinic

Toronto, Ontario, M2K 1E2, Canada

Location

The Center for Addiction and Mental Health

Toronto, Ontario, M5T 2S1, Canada

Location

Related Links

• Abstract of results presented at the American Association of Naturopathic Physician's convention in August, 2010

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

• Heather Boon, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

• Umesh Jain, MD

  The Center for Addiction and Mental Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: June 20, 2008
• First Posted: June 25, 2008
• Study Start: September 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: October 19, 2015

Record last verified: 2015-10

Locations

CA (2)