Attention Deficit Hyperactivity DisorderPhase 3NCT01022229
The Safety and Efficacy of a Compound Natural Health Product in Children With Attention Deficit Hyperactivity Disorder (ADHD)
A Phase 3 study testing Compound Natural Health Product in people with Attention Deficit Hyperactivity Disorder, run by The Canadian College of Naturopathic Medicine at 1 site in Canada.
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. 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?
- Compound Natural Health Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2013to Nov 2015
- Phase
- Phase 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
1 site in 1 country.
About this study
Official title: Phase 3 Study of a Compound Natural Health Product in Children With ADHD
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.
Read the detailed 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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Compound Natural Health Product, Placebo
- 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.
Compound Natural Health ProductDietary supplement
Also called Zinc, Magnesium, Vitamin B6, Vitamin C
- 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
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Compound Natural Health Product | Experimental | 15 study participants who will receive the compound natural health product. Receives: Dietary Supplement: Compound Natural Health Product |
| Placebo | Placebo comparator | 15 participants will receive placebo natural health product. Receives: Dietary Supplement: Placebo |
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 posted1 Dec 2009 (estimated)
- Study startNov 2013
- Primary completionNov 2015
- Study completionNov 2015
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Canadian College of Naturopathic Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Health Canada, Centre for Addiction and Mental Health, SickKids Foundation
- Responsible party
- Sponsor
- Investigators
- Umesh Jain, MD, Study director, The Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01022229
- Sponsor's protocol ID
- CCNM-0903
- Status last verified
- Jan 2016
- First submitted
- 26 Nov 2009
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of a Compound Natural Health Product in Children With ADHD
- ClinicalTrials.gov ID
- NCT01022229
- Acronym / sponsor ID
- CCNM-0903
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention Deficit Disorder, Pediatrics, Attention, Impulsivity, Complementary Therapies
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- The Canadian College of Naturopathic MedicineUniversity, hospital or other
- Collaborators
- Health Canada, Centre for Addiction and Mental Health, SickKids Foundation
- Study start
- Nov 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 1 Dec 2009 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compound Natural Health Product | Experimental | Dietary Supplement: Compound Natural Health Product15 study participants who will receive the compound natural health product. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo15 participants will receive placebo natural health product. |
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 |
|---|---|---|
| Compound Natural Health ProductAlso: Zinc, Magnesium, Vitamin B6, Vitamin C* 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 | Dietary supplement | Compound Natural Health Product |
| PlaceboPlacebo | Dietary supplement | Placebo |
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 28 Jan 2016.
Related trials for Attention Deficit Hyperactivity Disorder
RecruitingObservational study
National Pregnancy Registry for Psychiatric Medications
Pregnant Women, Psychotropic Drugs
Recruiting
Study of the Efficacy of Sulforaphane in Children Aged 6 to 12 With Attention Deficit Disorder With or Without Hyperactivity
Attention Deficit Disorder
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-3)
ADHD
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.
Umesh Jain, MD study director
The Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Compound Natural Health Product in people with Attention Deficit Hyperactivity Disorder, run by The Canadian College of Naturopathic Medicine at 1 site 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 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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 28 Jan 2016.