Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000308291
Ethics application status
Approved
Date submitted
22/04/2009
Date registered
19/05/2009
Date last updated
30/01/2019
Date data sharing statement initially provided
30/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of a nutritional supplement on attention and mood in adults with Attention-Deficit/Hyperactivity Disorder (ADHD)
Scientific title
Investigation into the effect of a nutritional supplement on attention and mood in a clinical sample of adults with Attention-Deficit/Hyperactivity Disorder (ADHD): a double blind randomized placebo controlled trial with open label extension.
Secondary ID [1] 252504 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention-Deficit/Hyperactivity Disorder 4630 0
Mood instability 4631 0
Condition category
Condition code
Mental Health 4930 4930 0 0
Other mental health disorders
Mental Health 4931 4931 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Double blind randomized controlled trial (RCT) comparing a mineral and vitamin supplement (EMpowerplus) with a placebo followed with an open-label extension. The intervention consists of a micronutrient formula called Empowerplus containing 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, Truehope.com. Patients swallow 15 capsules a day divided into three doses of 5 pills each dose for a total of 8 weeks. They then enter an open label trial for a further 8 weeks with the same dose of EMpowerplus.
Intervention code [1] 4390 0
Treatment: Other
Comparator / control treatment
Placebo: The placebo consists of riboflavin, fiber acacia gum, Maltodextrin, and cocoa powder. Patients swallow 15 capsules a day divided into three doses of 5 pills each dose for a total of 8 weeks. They then enter an open label trial for a further 8 weeks with the same dose of EMpowerplus (ingredients described above).
Control group
Placebo

Outcomes
Primary outcome [1] 5777 0
Conners Adult ADHD Rating Scales which assesses ADHD symptoms including inattention, hyperactivity, impulsivity, and emotional lability. There are clinician, observer and self forms.
Timepoint [1] 5777 0
baseline, 8 weeks (end of placebo phase), 16 weeks (end of open label phase) and 1 year follow up
Primary outcome [2] 5778 0
Montgomery-Asberg Depression Rating Scale which assesses low mood symptoms over the past week
Timepoint [2] 5778 0
every visit: patients will be seen weekly for the first two weeks and then every fortnight thereafter to 8 weeks. When they enter the open label trial, they will be seen weekly for the first two weeks and then fortnightly to the end of the trial (that is after 8 weeks). Therefore, there will be 5 visits during the randomized controlled trial (RCT) phase and five visits during the open-label trial and 1 year follow up
Primary outcome [3] 5779 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 [3] 5779 0
every visit: patients will be seen weekly for the first two weeks and then every fortnight thereafter to 8 weeks. When they enter the open label trial, they will be seen weekly for the first two weeks and then fortnightly to the end of the trial (that is after 8 weeks). Therefore, there will be 5 visits during the RCT phase and five visits during the open-label trial and one year follow-up.
Secondary outcome [1] 241740 0
The Longitudinal Interval Follow-up Evaluation - Range of Impaired Functioning Tool (LIFE-RIFT) to measure quality of life
Timepoint [1] 241740 0
baseline, 8 weeks following commencement of treatment, 16 weeks following commencement of treatment and one year follow up
Secondary outcome [2] 241741 0
Depression, Anxiety and Stress Scale
Timepoint [2] 241741 0
Baseline, 8 weeks following commencement of treatment, 16 weeks following commencement of treatment
Secondary outcome [3] 241742 0
Novaco Anger Scale
Timepoint [3] 241742 0
baseline, 8 weeks following commencement of treatment, 16 weeks following commencement of treatment
Secondary outcome [4] 241743 0
Outcome Questionnaire which assesses psychiatric symptoms generally such as anxiety, depression, etc.
Timepoint [4] 241743 0
baseline, 8 weeks following commencement of treatment, 16 weeks following commencement of treatment
Secondary outcome [5] 241744 0
Young Mania Rating Scale which assesses elevated moods consistent with a manic episode
Timepoint [5] 241744 0
every visit: patients will be seen weekly for the first two weeks and then every fortnight thereafter to 8 weeks. When they enter the open label trial, they will be seen weekly for the first two weeks and then fortnightly to the end of the trial (that is after 8 weeks). Therefore, there will be 5 visits during the RCT phase and five visits during the open-label trial.
Secondary outcome [6] 241745 0
Global Assessment of Functioning, a scale used to classify individuals based on the level of current symptomatology.
Timepoint [6] 241745 0
every visit: patients will be seen weekly for the first two weeks and then every fortnight thereafter to 8 weeks. When they enter the open label trial, they will be seen weekly for the first two weeks and then fortnightly to the end of the trial (that is after 8 weeks). Therefore, there will be 5 visits during the RCT phase and five visits during the open-label trial and one year follow-up.
Secondary outcome [7] 241746 0
Neurocognitive Functioning assessed using the Delis-Kaplan Executive Functioning Scale (DKEFS), Conners Continuous Performance Task (CCPT), Rapid Automatized Naming (RAN), Wide Range Assessment of Memory and Learning (WRAML-II), Complex Figures, Rey Auditory Verbal Learning Test (RVALT), Processing Speed and working Memory subtest of the Wechsler Adult Intelligent Scale (WAIS-III)
Timepoint [7] 241746 0
baseline, 8 weeks following commencement of treatment

Eligibility
Key inclusion criteria
1.Participants are older than 16 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.
Minimum age
16 Years
Maximum age
75 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, multiple sclerosis (MS), narcolepsy), 2) any serious medical condition for which major medical interventions was anticipated during the trial, 3) any patient known to be allergic to the ingredients of the intervention, 4) pregnancy or breastfeeding (pregnancy testing occurred at baseline and monthly thereafter), 5) evidence of untreated or unstable thyroid disease (thyroid testing will occur at baseline), 6) any known abnormality of mineral metabolism (e.g., Wilson’s disease, haemochromatosis), 7) evidence of substance dependence within the previous month, 8) any other medication with primarily central nervous system activity, including mood stabilizers (participants must have been off of these medications for a minimum of 4 weeks prior to the trial), 9) patients were excluded temporarily if they had taken an oral antibiotic in the previous 6 weeks (if an antibiotic was started during the course of the trial, that patient was withdrawn from the study), 10) any type of nutritional or herbal supplement, known to have a centrally-acting effect (patients who had been taking supplements such as echinacea, chondroitin, or glucosamine could enter the study if a) they have been taking these agents for at least one month prior to the study, and b) they continued on these agents throughout the study), and 11) 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
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Provided that an individual meets the inclusion criteria and does not meet exclusion criteria, the person is allocated the next available number. All pills (ie active ingredient or placebo) have been pre-packaged by the pharmacy who holds the randomization code. A sealed envelope is contained within each pill package only to be opened in an emergency (ie patient deteriorates significantly).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization was done using software produced by www.randomization.com. Four lists were generated and the pharmacy randomly chose one list to use for the randomization.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The randomized phase is followed with an open-label trial
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/05/2009
Actual
20/05/2009
Date of last participant enrolment
Anticipated
Actual
14/05/2012
Date of last data collection
Anticipated
Actual
1/06/2013
Sample size
Target
80
Accrual to date
Final
80
Recruitment outside Australia
Country [1] 1735 0
New Zealand
State/province [1] 1735 0

Funding & Sponsors
Funding source category [1] 4812 0
University
Name [1] 4812 0
University of Canterbury
Country [1] 4812 0
New Zealand
Funding source category [2] 285458 0
Charities/Societies/Foundations
Name [2] 285458 0
Vic Davis Memorial Trust
Country [2] 285458 0
New Zealand
Primary sponsor type
Individual
Name
Julia Rucklidge
Address
Department of Psychology
University of Canterbury
Private Bag 4800
Christchurch, Canterbury
8140
Country
New Zealand
Secondary sponsor category [1] 4345 0
None
Name [1] 4345 0
Address [1] 4345 0
Country [1] 4345 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6857 0
the Upper South A Regional Ethics Committee
Ethics committee address [1] 6857 0
Ministry of Health 4th floor 250 Oxford St (PO Box 3877)
Christchurch, Canterbury
8011
Ethics committee country [1] 6857 0
New Zealand
Date submitted for ethics approval [1] 6857 0
Approval date [1] 6857 0
27/11/2008
Ethics approval number [1] 6857 0
URA/08/09/062

Summary
Brief summary
It has been proposed that some vitamins and minerals (together known as micronutrients) might help people with mood instability to stabilize their mood. When a new idea such as this comes along, it must be studied first in a variety of people (referred to as case series), and then in a controlled trial. The case series that have been carried out on EMPowerplus suggest that it might help to stabilize mood and help with some symptoms of ADHD. Often when people participate in trials, such as an open-label trial, they get better simply because of the contact with a health professional, the care they receive and the belief that they will get better. An RCT will help determine with more confidence the effect these pills have on the symptoms being measured.
Trial website
Trial related presentations / publications
Rucklidge, J. J., Frampton, C., Gorman, B., & Boggis, A. (in press). Vitamin-mineral treatment of ADHD in adults: A double-blind, randomized, placebo controlled trial. British Journal of Psychiatry.
Public notes

Contacts
Principal investigator
Name 29510 0
A/Prof Julia Rucklidge
Address 29510 0
Department of Psychology
University of Canterbury
Private Bag 4800
Christchurch
8140
New Zealand
Country 29510 0
New Zealand
Phone 29510 0
+6433642987
Fax 29510 0
Email 29510 0
[email protected]
Contact person for public queries
Name 12757 0
Julia Rucklidge
Address 12757 0
Department of Psychology
University of Canterbury
Private Bag 4800
Christchurch, Canterbury
8140
Country 12757 0
New Zealand
Phone 12757 0
+64 3 3642987 ext. 7959
Fax 12757 0
+64 3 3642181
Email 12757 0
[email protected]
Contact person for scientific queries
Name 3685 0
Julia Rucklidge
Address 3685 0
Department of Psychology
University of Canterbury
Private Bag 4800
Christchurch, Canterbury
8140
Country 3685 0
New Zealand
Phone 3685 0
+64 3 3642987 ext. 7959
Fax 3685 0
+64 3 3642181
Email 3685 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The participants did not consent to this level of data sharing


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
No additional documents have been identified.