Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000202268
Ethics application status
Approved
Date submitted
17/03/2009
Date registered
21/04/2009
Date last updated
30/01/2019
Date data sharing statement initially provided
30/01/2019
Date results information initially provided
30/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of a nutritional supplement on attention and mood in adults with Attention-Deficit/Hyperactivity Disorder
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) and mood instability: open label pilot study.
Secondary ID [1] 283726 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention-Deficit/Hyperactivity Disorder 4485 0
Mood instability 4486 0
Condition category
Condition code
Mental Health 4764 4764 0 0
Other mental health disorders
Mental Health 4765 4765 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 4235 0
Treatment: Other
Comparator / control treatment
There is no control as this is a single group study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5628 0
Conners Adult ADHD Rating Scale which assesses ADHD symptoms including inattention, hyperactivity and impulsivity
Timepoint [1] 5628 0
baseline, 8 weeks
Primary outcome [2] 5629 0
Montgomery Asberg Depression Rating Scale
Timepoint [2] 5629 0
baseline, 8 weeks
Primary outcome [3] 5630 0
The Young Mania Rating Scale which assesses symptoms of heightened and elevated mood such as mania
Timepoint [3] 5630 0
baseline, 8 weeks
Secondary outcome [1] 241504 0
The Range of Impaired Functioning Tool (LIFE-RIFT) to measure quality of life
Timepoint [1] 241504 0
baseline, 8 weeks
Secondary outcome [2] 241505 0
Depression, Anxiety, and Stress Scale
Timepoint [2] 241505 0
baseline, 8 weeks
Secondary outcome [3] 241506 0
Novaco Anger Scale which assesses anger management
Timepoint [3] 241506 0
baseline, 8 weeks
Secondary outcome [4] 241507 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 [4] 241507 0
baseline, 8 weeks

Eligibility
Key inclusion criteria
1.Participants are older than 18 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 and show signs of some mood instability.
Minimum age
18 Years
Maximum age
No limit
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
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
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2008
Actual
3/03/2008
Date of last participant enrolment
Anticipated
Actual
15/10/2008
Date of last data collection
Anticipated
Actual
1/01/2009
Sample size
Target
15
Accrual to date
Final
14
Recruitment outside Australia
Country [1] 1684 0
New Zealand
State/province [1] 1684 0

Funding & Sponsors
Funding source category [1] 4675 0
University
Name [1] 4675 0
University of Canterbury
Country [1] 4675 0
New Zealand
Primary sponsor type
Individual
Name
Julia Rucklidge
Address
Department of Psychology
Private Bag 4800
Christchurch, Canterbury
8140
Country
New Zealand
Secondary sponsor category [1] 4221 0
None
Name [1] 4221 0
Address [1] 4221 0
Country [1] 4221 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6714 0
the Upper South A Regional Ethics Committee
Ethics committee address [1] 6714 0
Ministry of Health 4th floor 250 Oxford St (PO Box 3877), Christchurch
8011
Ethics committee country [1] 6714 0
New Zealand
Date submitted for ethics approval [1] 6714 0
Approval date [1] 6714 0
19/02/2008
Ethics approval number [1] 6714 0
URA/07/11/080

Summary
Brief summary
There is very little research into the impact of complementary alternative medicines (CAM) on psychiatric illness yet thousands of New Zealanders use CAM as part of their treatments for all types of ailments. This study aims to investigate one type of CAM called Empowerplus (a micronutrient formula with 36 ingredients). Overseas studies are promising in that Empowerplus has been found to be effective in the treatment of Bipolar Disorder in adults, established through open-series designs, with the suggestion it may improve overall mood stability. However, to date no study has investigated its effect on attention or self-regulation despite the fact that thousands of families seek alternative treatments for ADHD. This study aims to do a pilot trial of MCN-36 with 25 ADHD adults with mood instability to investigate feasibility issues and initial impact of Empowerplus on attention and mood to determine if a larger scale trial should be launched.
Trial website
Trial related presentations / publications
1. Rucklidge, J. J., Johnstone, J., Harrison, R. (2011). Effect of micronutrients on neurocognitive functioning in adults with ADHD and Severe Mood Dysregulation: A pilot study. Journal of Alternative and Complementary Medicine, 17(12), 1-7.
2. Rucklidge, J. J., Taylor, M. R., Whitehead, K. A. (2011). Effect of micronutrients on behaviour and mood in adults with ADHD: Evidence from an 8-week open label trial with natural extension. Journal of Attention Disorders, 15(1), 79-91. doi:10.1177/1087054709356173.
Public notes

Contacts
Principal investigator
Name 29407 0
A/Prof Julia Rucklidge
Address 29407 0
Private Bag 4800
Dept of Psychology
University of Canterbury
Christchurch
8140
Country 29407 0
New Zealand
Phone 29407 0
+6433642987
Fax 29407 0
Email 29407 0
[email protected]
Contact person for public queries
Name 12654 0
A/Prof Julia Rucklidge
Address 12654 0
Department of Psychology
University of Canterbury
Private Bag 4800
Christchurch, Canterbury
8140
Country 12654 0
New Zealand
Phone 12654 0
+64 3 3642987 ext. 7959
Fax 12654 0
+64 3 3642181
Email 12654 0
[email protected]
Contact person for scientific queries
Name 3582 0
A/Prof Julia Rucklidge
Address 3582 0
Department of Psychology
Univerasity of Canterbury
Private Bag 4800
Christchurch, Canterbury
8140
Country 3582 0
New Zealand
Phone 3582 0
+64 3 3642987 ext. 7959
Fax 3582 0
+64 3 3642181
Email 3582 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
No additional documents have been identified.