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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00704990
• Other study ID #: CCNM-083-ADHD
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 20, 2008
• Last updated: October 15, 2015
• Start date: September 2008
• Est. completion date: December 2009

Study information

• Verified date: October 2015
• 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

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• 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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• Zinc, Magnesium, Vitamin B6, Vitamin C (Compound Natural Health Product for ADHD)
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

Locations

Country	Name	City	State
Canada	Robert Schad Naturopathic Clinic	Toronto	Ontario
Canada	The Center for Addiction and Mental Health	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
Kieran Cooley	Centre for Addiction and Mental Health, The Canadian College of Naturopathic Medicine, University of Toronto

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

External Links

•   Abstract of results presented at the American Association of Naturopathic Physician's convention in August, 2010