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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01022229
• Other study ID #: CCNM-0903
• Status: Completed
• Phase: Phase 3
• First received: November 26, 2009
• Last updated: January 27, 2016
• Start date: November 2013
• Est. completion date: November 2015

Study information

• Verified date: January 2016
• Source: The Canadian College of Naturopathic Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Dietary Supplement:
• Compound Natural Health Product
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
• Placebo
Placebo

Locations

Country	Name	City	State
Canada	Robert Schad Naturopathic Clinic	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
The Canadian College of Naturopathic Medicine	Centre for Addiction and Mental Health, Health Canada, SickKids Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Connors-3 Parent Rating Scale		Baseline, week 5, week 10 and follow-up at week 20	No
Secondary	Nutritional status of zinc and magnesium		Week 0 and week 10	No
Secondary	Adverse events		Throughout study	Yes
Secondary	SNAP-IV Parent ADHD questionnaire		Week 0, week 5 and week 10	No