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| Name | Class |
|---|---|
| The Canadian College of Naturopathic Medicine | OTHER |
| University of Toronto | OTHER |
| Centre for Addiction and Mental Health | OTHER |
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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.
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 Once enrolled, children can withdraw from the study at any time if assent to participate is withdrawn.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | All study participants take part in the experimental arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Connors-3 Parent Rating Scale | Baseline, week 5, week 10 and follow-up at week 20 |
| Measure | Description | Time Frame |
|---|---|---|
| Nutritional status of zinc and magnesium | Week 0 and week 10 | |
| Adverse events | Throughout study | |
| SNAP-IV Parent ADHD questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heather Boon, PhD | University of Toronto | Principal Investigator |
| Umesh Jain, MD | The Center for Addiction and Mental Health | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert Schad Naturopathic Clinic | Toronto | Ontario | M2K 1E2 | Canada | ||
| The Center for Addiction and Mental Health |
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| Label | URL |
|---|---|
| Abstract of results presented at the American Association of Naturopathic Physician's convention in August, 2010 | View source |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D007175 | Impulsive Behavior |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015032 | Zinc |
| D008274 | Magnesium |
| D025101 | Vitamin B 6 |
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
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|
|
| Week 0, week 5 and week 10 |
| Toronto |
| Ontario |
| M5T 2S1 |
| Canada |
| D008670 |
| Metals |
| D008673 | Metals, Alkaline Earth |
| D019565 | Metals, Light |
| D010847 | Picolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |