Attention Deficit Hyperactivity DisorderPhase 2/3NCT00704990
Combination Natural Health Product in Children With Attention Deficit/Hyperactivity Disorder (ADHD)
A Phase 2/3 study testing Zinc, Magnesium, Vitamin B6, Vitamin C (Compound Natural Health Product for ADHD) in people with Attention Deficit Hyperactivity Disorder, run by Kieran Cooley at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Zinc, Magnesium, Vitamin B6, Vitamin C (Compound Natural Health Product for ADHD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2008to Dec 2009
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Robert Schad Naturopathic Clinic
Toronto, Ontario, M2K 1E2
The Center for Addiction and Mental Health
Toronto, Ontario, M5T 2S1
About this study
Official title: The Safety and Efficacy of a Compound Natural Health Product in Children With Attention Deficit/Hyperactivity Disorder: A Pilot Study
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.
Read the 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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Zinc, Magnesium, Vitamin B6, Vitamin C (Compound Natural Health Product for ADHD)
- Keywords
- Attention Deficit Disorder, Pediatrics, Attention, Impulsivity, Complementary Therapies
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc, Magnesium, Vitamin B6, Vitamin C (Compound Natural Health Product for ADHD)Dietary supplement
Also called Zinc, Magnesium, Vitamin B6, Vitamin C
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
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | All study participants take part in the experimental arm Receives: Dietary Supplement: Zinc, Magnesium, Vitamin B6, Vitamin C (Compound Natural Health Product for ADHD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Connors-3 Parent Rating Scale
Measured: Baseline, week 5, week 10 and follow-up at week 20
Secondary outcomes (3)
Nutritional status of zinc and magnesium
Measured: Week 0 and week 10
Adverse events
Measured: Throughout study
SNAP-IV Parent ADHD questionnaire
Measured: Week 0, week 5 and week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kieran Cooley
- Sponsor type
- University, hospital or other
- Collaborators
- The Canadian College of Naturopathic Medicine, University of Toronto, Centre for Addiction and Mental Health
- Responsible party
- Sponsor-investigator, Kieran Cooley, The Canadian College of Naturopathic Medicine
- Investigators
- Heather Boon, PhD, Principal investigator, University of TorontoUmesh Jain, MD, Study director, The Center for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00704990
- Sponsor's protocol ID
- CCNM-083-ADHD
- Status last verified
- Oct 2015
- First submitted
- 20 Jun 2008
- Last updated
- 19 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of a Compound Natural Health Product in Children With Attention Deficit/Hyperactivity Disorder: A Pilot Study
- ClinicalTrials.gov ID
- NCT00704990
- Acronym / sponsor ID
- CCNM-083-ADHD
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention Deficit Disorder, Pediatrics, Attention, Impulsivity, Complementary Therapies
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Kieran CooleyUniversity, hospital or other
- Collaborators
- The Canadian College of Naturopathic Medicine, University of Toronto, Centre for Addiction and Mental Health
- Study start
- Sep 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 25 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Dietary Supplement: Zinc, Magnesium, Vitamin B6, Vitamin C (Compound Natural Health Product for ADHD)All study participants take part in the experimental arm |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zinc, Magnesium, Vitamin B6, Vitamin C (Compound Natural Health Product for ADHD)Also: Zinc, Magnesium, Vitamin B6, Vitamin CWeight 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 | Dietary supplement | A |
Primary outcome
Connors-3 Parent Rating Scale
Time frame: Baseline, week 5, week 10 and follow-up at week 20
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2015.
- Abstract of results presented at the American Association of Naturopathic Physician's convention in August, 2010Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Boon, PhD principal investigator
University of Toronto
Umesh Jain, MD study director
The Center for Addiction and Mental Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Zinc, Magnesium, Vitamin B6, Vitamin C (Compound Natural Health Product for ADHD) in people with Attention Deficit Hyperactivity Disorder, run by Kieran Cooley at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Connors-3 Parent Rating Scale (time frame: Baseline, week 5, week 10 and follow-up at week 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2015.