Skip to main content
OpenTrials
Completed

NCT Number: NCT00704990

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

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.

Completed

Looking for future studies?

Notify Me

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 2 / Phase 3

Primary location

Robert Schad Naturopathic Clinic, Toronto, Ontario, Canada

Loading trial locations.

About this study

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 Once enrolled, children can withdraw from the study at any time if assent to participate is withdrawn.

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

Zinc, Magnesium, Vitamin B6, Vitamin C (Compound Natural Health Product for ADHD)

Dietary Supplement

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

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

Kieran Cooley

Other

Collaborators

  • Centre for Addiction and Mental Health
  • The Canadian College of Naturopathic Medicine
  • University of Toronto

Registry information

Official study title

The Safety and Efficacy of a Compound Natural Health Product in Children With Attention Deficit/Hyperactivity Disorder: A Pilot Study

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 25, 2008
Registry last updated
Oct 19, 2015

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.