Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000645853
Ethics application status
Approved
Date submitted
18/06/2012
Date registered
19/06/2012
Date last updated
30/01/2019
Date data sharing statement initially provided
30/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot study investigating the impact of micronutrients on children with Attention-Deficit/Hyperactivity Disorder (ADHD)
Scientific title
Investigation into the effect of micronutrients on mood and behaviour in children with Attention-Deficit/Hyperactivity Disorder (ADHD): a study using single case ABAB design.
Secondary ID [1] 280688 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
ADHD 286716 0
Condition category
Condition code
Mental Health 287017 287017 0 0
Other mental health disorders
Alternative and Complementary Medicine 287034 287034 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ABAB design (on-off-on-off) using a vitamin and mineral formula (EMPowerplus) for the treatment of ADHD in children. Empowerplus contains 36 ingredients: 14 vitamins, 16 minerals, 3 amino acids and 3 antioxidants. A list of the ingredients can be found on the company’s website, www.truehope.com. Participants first take 8 pills a day for 4 weeks; if there is no response, the dose is increased to 15 pills a day for another 4 weeks. After 8 weeks taking pills, participants are taken off for 4 weeks, put back on at the optimal dose for 8 weeks and then taken off again for 4 weeks.
Intervention code [1] 285099 0
Treatment: Other
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287353 0
The Clinical Global Impressions Severity (CGI-S) and Improvement (CGI-I) Scales which are clinician rated questions assessing the severity of the illness (e.g., mild, moderate, severe) and any changes that have occurred since the last visit (e.g. no change, much improved, very much improved)
Timepoint [1] 287353 0
Every visit (once every two weeks) through out the 24 week trial period and follow up
Primary outcome [2] 287354 0
ADHD rating scales
Timepoint [2] 287354 0
Conners Parent and Teacher Rating Scales completed at switch points and a short version completed every two weeks throughout the 24 week trial period and at follow up
Primary outcome [3] 287355 0
Strengths and Difficulties Questionnaire (SDQ) is a brief screening questionnaire for child mental health problems that is suitable for parents and teachers to fill out
Timepoint [3] 287355 0
Switch points of ABAB design as well as baseline
Secondary outcome [1] 297972 0
Children's Global Assessment Scale (CGAS). The CGAS is used to by the clinician to assess the overall severity of disturbance in children. The CGAS is a single numerical scale from1 through 100 that is separated into 10-point sections indicating the child's level of functioning.
Timepoint [1] 297972 0
Every visit (once every two weeks) throughout the 24 week trial period and follow up
Secondary outcome [2] 297973 0
Child Depression Rating Scale (CDRS) is a 16-item measure, used for children aged 6-12 years old, measuring the severity of depression.
Timepoint [2] 297973 0
Every visit (once every two weeks) throughout the 24 week trial period and follow up
Secondary outcome [3] 297974 0
The Young Mania Rating Scale assesses manic-like behaviours in children and adults
Timepoint [3] 297974 0
Every visit (once every two weeks) throughout the 24 week trial period and follow up
Secondary outcome [4] 297975 0
Child Mania Rating Scale, Parent Version (CMRS-P)
Timepoint [4] 297975 0
Every visit (once every two weeks) throughout the 24 week trial period and follow up
Secondary outcome [5] 297976 0
Conners Continuous Performance Test (CPT-II). The CPT-II (Connors, 2000) is used as a measure of complex cognitive functioning, including attention, visual-motor speed, visual-motor integration, hyperactivity and impulsivity
Timepoint [5] 297976 0
Switch points of ABAB design as well as baseline

Eligibility
Key inclusion criteria
1. Participants are between 8-12 years of age.
2. Each participant must have a level of understanding sufficient to complete the questionnaires and examinations required by the protocol and be considered reliable and compliant with the protocol (including the ingestion of as many as 15 capsules/day).
3. Participants must be able to eat at least a snack three times per day, so that the capsules will not be ingested on an empty stomach.
4. Participants meet criteria for ADHD as assessed by the K-SADS (Kaufman, et al., 1997), the Conners Rating Scales (score greater than 70 on either parent or teacher form; (Conners, 1997).
Minimum age
8 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Neurological disorder involving brain or other central function (e.g., epilepsy, MS, narcolepsy). Purely peripheral neurological problems are not excluded (e.g., Raynaud’s, peripheral diabetic neuropathy).
2. Any serious medical condition for which major medical interventions are anticipated during the duration of the trial.
3. Any patient known to be allergic to the ingredients of the intervention (including ginkgo biloba, germanium sesquioxide, or grape seed) will be excluded.
4. Evidence of untreated or unstable thyroid disease (thyroid testing will occur at baseline).
5. Any known abnormality of mineral metabolism (e.g., Wilson’s disease, haemochromatosis).
6. Any other medication with primarily central nervous system activity, including mood stabilizers. Participants must have been off of these medications for a minimum of four weeks prior to the trial.
7. Patients will be excluded temporarily if they have taken an oral antibiotic in the previous 6 weeks.
8. Any type of nutritional or herbal supplement, known to have a centrally-acting effect, will result in a patient's exclusion. However, patients who have been taking supplements such as echinacea, chondroitin, or glucosamine may enter the study if a) they have been taking these agents for at least one month prior to the study, and b) they continue on these agents throughout the study. We will permit people to take as much as 1 g/day of EPA and DHA combined.
9. Any subject judged clinically to be at serious risk for suicide or violence in the opinion of the researchers.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2011
Actual
1/09/2011
Date of last participant enrolment
Anticipated
Actual
18/03/2013
Date of last data collection
Anticipated
Actual
30/08/2014
Sample size
Target
15
Accrual to date
Final
14
Recruitment outside Australia
Country [1] 4366 0
New Zealand
State/province [1] 4366 0
Canterbury

Funding & Sponsors
Funding source category [1] 285455 0
Charities/Societies/Foundations
Name [1] 285455 0
Vic Davis Memorial Trust
Country [1] 285455 0
New Zealand
Funding source category [2] 285466 0
University
Name [2] 285466 0
Department of Psychology, University of Canterbury
Country [2] 285466 0
New Zealand
Primary sponsor type
University
Name
Department of Psychology, University of Canterbury
Address
Private Bag 4800
Ilam 8140
Christchurch
Country
New Zealand
Secondary sponsor category [1] 284309 0
None
Name [1] 284309 0
Address [1] 284309 0
Country [1] 284309 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287470 0
Lower South Regional Ethics Committee
Ethics committee address [1] 287470 0
Ethics committee country [1] 287470 0
New Zealand
Date submitted for ethics approval [1] 287470 0
Approval date [1] 287470 0
29/06/2011
Ethics approval number [1] 287470 0
HEC 2011/44

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34325 0
A/Prof Julia Rucklidge
Address 34325 0
Private Bag 4800
Department of Psychology
University of Canterbury
Christchurch
8140
Country 34325 0
New Zealand
Phone 34325 0
+6433642987
Fax 34325 0
Email 34325 0
[email protected]
Contact person for public queries
Name 17572 0
Julia Rucklidge
Address 17572 0
Department of Psychology
University of Canterbury
Private Bag 4800
Christchurch, Canterbury
8140
Country 17572 0
New Zealand
Phone 17572 0
+64 3 3642987 ext. 7959
Fax 17572 0
+64 3 3642181
Email 17572 0
[email protected]
Contact person for scientific queries
Name 8500 0
Julia Rucklidge
Address 8500 0
Department of Psychology
University of Canterbury
Private Bag 4800
Christchurch, Canterbury
8140
Country 8500 0
New Zealand
Phone 8500 0
+64 3 3642987 ext. 7959
Fax 8500 0
+64 3 3642181
Email 8500 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseClinically Significant Symptom Reduction in Children with Attention-Deficit/Hyperactivity Disorder Treated with Micronutrients: An Open-Label Reversal Design Study.2015https://dx.doi.org/10.1089/cap.2015.0105
N.B. These documents automatically identified may not have been verified by the study sponsor.