The Safety and Efficacy of a Compound Natural Health Product in Children With Attention Deficit Hyperactivity Disorder (ADHD)
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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 |
- Connors-3 Parent Rating Scale [ Time Frame: Baseline, week 5, week 10 and follow-up at week 20 ] [ Designated as safety issue: No ]
- 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: | June 2013 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | June 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
Doses are weight based. Chewable tablets are taken 2 times/day with food for the duration of the study Other Names:
|
|
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 |
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| Canada, Ontario | |
| Robert Schad Naturopathic Clinic | Not yet recruiting |
| Toronto, Ontario, Canada, M2K 1E2 | |
| Contact: Kieran Cooley, BSc, ND 416.498.1255 ext 229 kcooley@cnm.edu | |
| Contact: Tara J. Campbell, BA, ND 416.498.1255 ext 415 tcampbell@ccnm.edu | |
| 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: | January 14, 2013 |
| 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 May 22, 2013