Combination Natural Health Product in Children With Attention Deficit/Hyperactivity Disorder (ADHD) - Full Text View

Sponsor:	The Canadian College of Naturopathic Medicine
Collaborators:	University of Toronto Centre for Addiction and Mental Health
Information provided by:	The Canadian College of Naturopathic Medicine
ClinicalTrials.gov Identifier:	NCT00704990

Purpose

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.

Condition	Intervention	Phase
Attention Deficit Hyperactivity Disorder	Dietary Supplement: Zinc, Magnesium, Vitamin B6, Vitamin C (Compound Natural Health Product for ADHD)	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	The Safety and Efficacy of a Compound Natural Health Product in Children With Attention Deficit/Hyperactivity Disorder: A Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder Child Mental Health Dietary Supplements Mental Health

Drug Information available for: Ascorbic acid Pyridoxine hydrochloride Pyridoxine Magnesium Vitamin B 6

U.S. FDA Resources

Further study details as provided by The Canadian College of Naturopathic Medicine:

Primary Outcome Measures:

Connors-3 Parent Rating Scale [ Time Frame: Baseline, week 5, week 10 and follow-up at week 20 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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:	September 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental All study participants take part in the experimental arm	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

Detailed 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.

Eligibility

Ages Eligible for Study:	6 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00704990

Locations

Canada, Ontario
Robert Schad Naturopathic Clinic
Toronto, Ontario, Canada, M2K 1E2
The Center for Addiction and Mental Health
Toronto, Ontario, Canada, M5T 2S1

Sponsors and Collaborators

The Canadian College of Naturopathic Medicine

University of Toronto

Centre for Addiction and Mental Health

Investigators

Principal Investigator:	Heather Boon, PhD	University of Toronto
Study Director:	Umesh Jain, MD	The Center for Addiction and Mental Health

More Information

No publications provided

Responsible Party:	The Canadian College of Naturopathic Medicine ( Nick DeGroot/Dean )
Study ID Numbers:	CCNM-083-ADHD
Study First Received:	June 20, 2008
Last Updated:	October 6, 2009
ClinicalTrials.gov Identifier:	NCT00704990 History of Changes
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:

Antioxidants
Vitamin B Complex
Disease
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs
Nervous System Diseases
Attention Deficit and Disruptive Behavior Disorders
Protective Agents
Dyskinesias
Pharmacologic Actions
Vitamin B 6

Signs and Symptoms
Pathologic Processes
Attention Deficit Disorder with Hyperactivity
Pyridoxal
Mental Disorders
Vitamins
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Neurologic Manifestations
Pyridoxine
Micronutrients
Ascorbic Acid

ClinicalTrials.gov processed this record on February 08, 2010