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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by The Canadian College of Naturopathic Medicine
Sponsor:
Collaborators:
Health Canada
Centre for Addiction and Mental Health
SickKids Foundation
Information provided by (Responsible Party):
The Canadian College of Naturopathic Medicine
ClinicalTrials.gov Identifier:
NCT01022229
First received: November 26, 2009
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Dietary Supplement: Compound Natural Health Product
Dietary Supplement: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase 3 Study of a Compound Natural Health Product in Children With ADHD

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 ]

Estimated Enrollment: 30
Study Start Date: November 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Compound Natural Health Product
15 study participants who will receive the compound natural health product.
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

Other Names:
  • Zinc
  • Magnesium
  • Vitamin B6
  • Vitamin C
Placebo Comparator: Placebo
15 participants will receive placebo natural health product.
Dietary Supplement: Placebo
Placebo

Detailed Description:

The study is a randomized control, double blinded trial. A population of 30 children diagnosed with ADHD (n=30) will be randomly assigned to the NHP group (n=15) or a placebo group (n=15). The NHP group 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. The placebo group will be administered a chewable placebo tablet and will follow the same regimen. 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: NCT01022229

Locations
Canada, Ontario
Robert Schad Naturopathic Clinic Recruiting
Toronto, Ontario, Canada, M2K 1E2
Contact: Kieran Cooley, BSc, ND    416.498.1255 ext 324    kcooley@ccnm.edu   
Contact: Chris Knee, MSc, ND    416.498.1255 ext 420    cknee@ccnm.edu   
Principal Investigator: Kieran Cooley, ND         
Sponsors and Collaborators
The Canadian College of Naturopathic Medicine
Health Canada
Centre for Addiction and Mental Health
SickKids Foundation
Investigators
Study Director: Umesh Jain, MD The Centre for Addiction and Mental Health
  More Information

No publications provided

Responsible Party: The Canadian College of Naturopathic Medicine
ClinicalTrials.gov Identifier: NCT01022229     History of Changes
Other Study ID Numbers: CCNM-0903
Study First Received: November 26, 2009
Last Updated: July 7, 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
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014