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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01022229
Recruitment Status : Completed
First Posted : December 1, 2009
Last Update Posted : January 28, 2016
Health Canada
Centre for Addiction and Mental Health
SickKids Foundation
Information provided by (Responsible Party):
The Canadian College of Naturopathic Medicine

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.

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase 3 Study of a Compound Natural Health Product in Children With ADHD
Study Start Date : November 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Connors-3 Parent Rating Scale [ Time Frame: Baseline, week 5, week 10 and follow-up at week 20 ]

Secondary Outcome Measures :
  1. Nutritional status of zinc and magnesium [ Time Frame: Week 0 and week 10 ]
  2. Adverse events [ Time Frame: Throughout study ]
  3. SNAP-IV Parent ADHD questionnaire [ Time Frame: Week 0, week 5 and week 10 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01022229

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Canada, Ontario
Robert Schad Naturopathic Clinic
Toronto, Ontario, Canada, M2K 1E2
Sponsors and Collaborators
The Canadian College of Naturopathic Medicine
Health Canada
Centre for Addiction and Mental Health
SickKids Foundation
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Study Director: Umesh Jain, MD The Centre for Addiction and Mental Health

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Responsible Party: The Canadian College of Naturopathic Medicine Identifier: NCT01022229    
Other Study ID Numbers: CCNM-0903
First Posted: December 1, 2009    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2016
Keywords provided by The Canadian College of Naturopathic Medicine:
Attention Deficit Disorder
Complementary Therapies
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Vitamin B 6
Growth Substances
Physiological Effects of Drugs
Vitamin B Complex