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

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Dietary supplement: Zinc, Magnesium, Vitamin B6, Vitamin C (Compound Natural Health Product for ADHD)

Detailed Description

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 Once enrolled, children can withdraw from the study at any time if assent to participate is withdrawn.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M2K 1E2
      • Robert Schad Naturopathic Clinic
    • Toronto, Ontario, Canada, M5T 2S1
      • The Center for Addiction and Mental Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: A; All study participants take part in the experimental arm

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; Other Names: Magnesium; Vitamin C; Vitamin B6; Zinc

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Connors-3 Parent Rating Scale	Baseline, week 5, week 10 and follow-up at week 20

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events	Throughout study
Nutritional status of zinc and magnesium	Week 0 and week 10
SNAP-IV Parent ADHD questionnaire	Week 0, week 5 and week 10

Collaborators and Investigators

• Sponsor: Kieran Cooley
• Collaborators: Centre for Addiction and Mental Health; University of Toronto; The Canadian College of Naturopathic Medicine
• Investigators: Principal Investigator: Heather Boon, PhD, University of Toronto; Study Director: Umesh Jain, MD, The Center for Addiction and Mental Health

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: June 20, 2008
• First Submitted That Met QC Criteria: June 24, 2008
• First Posted (Estimate): June 25, 2008

Study Record Updates

• Last Update Posted (Estimate): October 19, 2015
• Last Update Submitted That Met QC Criteria: October 15, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Attention; Pediatrics; Impulsivity; Complementary Therapies; Attention Deficit Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Disease; Attention Deficit Disorder with Hyperactivity; Hyperkinesis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Trace Elements; Micronutrients; Antioxidants; Vitamins; Vitamin B Complex; Ascorbic Acid; Vitamin B 6; Pyridoxal; Pyridoxine; Zinc
• Other Study ID Numbers: CCNM-083-ADHD