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NCT Number: NCT01022229

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

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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Behavior Impulsive Behavior Mental Disorders Neurodevelopmental Disorders

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Robert Schad Naturopathic Clinic

Toronto, Ontario, M2K 1E2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Compound Natural Health Product

Dietary Supplement
  • 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

Dietary Supplement

Placebo

Primary outcomes

  1. Connors-3 Parent Rating Scale

    Time frame: Baseline, week 5, week 10 and follow-up at week 20

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

The Canadian College of Naturopathic Medicine

Other

Collaborators

  • Centre for Addiction and Mental Health
  • Health Canada
  • SickKids Foundation

Registry information

Official study title

Phase 3 Study of a Compound Natural Health Product in Children With ADHD

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 1, 2009
Registry last updated
Jan 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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