A Phase 3 interventional study of Compound Natural Health Product and Placebo in Attention Deficit Hyperactivity Disorder, sponsored by The Canadian College of Naturopathic Medicine. Completed at 1 site in Canada. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2016-01-28.
Sponsored by The Canadian College of Naturopathic Medicine · Phase 3, Interventional, and Treatment
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.
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.
729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.
This study's enrollment of 16 is below the median of 80 across 583 interventional studies indexed under Hyperkinesis.
Browse Hyperkinesis studies →The Canadian College of Naturopathic Medicine is the lead sponsor of 19 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
15 study participants who will receive the compound natural health product.
Dietary Supplement: Compound Natural Health Product
15 participants will receive placebo natural health product.
Dietary Supplement: Placebo
* 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
Also known as: Zinc, Magnesium, Vitamin B6, Vitamin C
Placebo
Connors-3 Parent Rating Scale
Time frame: Baseline, week 5, week 10 and follow-up at week 20
Nutritional status of zinc and magnesium
Time frame: Week 0 and week 10
Adverse events
Time frame: Throughout study
SNAP-IV Parent ADHD questionnaire
Time frame: Week 0, week 5 and week 10
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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The Canadian College of Naturopathic Medicine