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

This study has been completed.
Sponsor:
Collaborators:
The Canadian College of Naturopathic Medicine
University of Toronto
Centre for Addiction and Mental Health
Information provided by (Responsible Party):
Kieran Cooley, The Canadian College of Naturopathic Medicine
ClinicalTrials.gov Identifier:
NCT00704990
First received: June 20, 2008
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Dietary Supplement: Zinc, Magnesium, Vitamin B6, Vitamin C (Compound Natural Health Product for ADHD)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of a Compound Natural Health Product in Children With Attention Deficit/Hyperactivity Disorder: A Pilot Study

Resource links provided by NLM:


Further study details as provided by The Canadian College of Naturopathic Medicine:

Primary Outcome Measures:
  • Connors-3 Parent Rating Scale [ Time Frame: Baseline, week 5, week 10 and follow-up at week 20 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Nutritional status of zinc and magnesium [ Time Frame: Week 0 and week 10 ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  • SNAP-IV Parent ADHD questionnaire [ Time Frame: Week 0, week 5 and week 10 ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: September 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Zinc
  • Magnesium
  • Vitamin B6
  • Vitamin C

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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00704990

Locations
Canada, Ontario
Robert Schad Naturopathic Clinic
Toronto, Ontario, Canada, M2K 1E2
The Center for Addiction and Mental Health
Toronto, Ontario, Canada, M5T 2S1
Sponsors and Collaborators
Kieran Cooley
The Canadian College of Naturopathic Medicine
University of Toronto
Centre for Addiction and Mental Health
Investigators
Principal Investigator: Heather Boon, PhD University of Toronto
Study Director: Umesh Jain, MD The Center for Addiction and Mental Health
  More Information

Additional Information:
No publications provided

Responsible Party: Kieran Cooley, Principle Investigator, The Canadian College of Naturopathic Medicine
ClinicalTrials.gov Identifier: NCT00704990     History of Changes
Other Study ID Numbers: CCNM-083-ADHD
Study First Received: June 20, 2008
Last Updated: August 21, 2014
Health Authority: Canada: Health Canada

Keywords provided by The Canadian College of Naturopathic Medicine:
Attention Deficit Disorder
Pediatrics
Attention
Impulsivity
Complementary Therapies

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Disease
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms
Ascorbic Acid
Pyridoxal
Pyridoxine
Vitamin B 6
Vitamin B Complex
Vitamins
Antioxidants
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on October 29, 2014