Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000671864
Ethics application status
Approved
Date submitted
21/06/2012
Date registered
22/06/2012
Date last updated
30/01/2019
Date data sharing statement initially provided
30/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study investigating the effect of micronutrients on anxiety and stress in children.
Scientific title
A pilot investigation into the effect of micronutrients on anxiety and stress in Canterbury children: a multiple baseline design.
Secondary ID [1] 280690 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stress 286718 0
anxiety 286768 0
Condition category
Condition code
Mental Health 287020 287020 0 0
Anxiety
Alternative and Complementary Medicine 287075 287075 0 0
Other alternative and complementary medicine

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. The dose will be 4 oral capsules twice a day. The design consists of three multiple baseline, 5 per group. Each group starts at a different time from baseline as determined by randomly assigning each person to one of three starting points from baseline (1, 2 or 3 weeks). Each group takes the micronutrients for 8 weeks. Participants are followed 3 months post-trial
Intervention code [1] 285100 0
Treatment: Other
Comparator / control treatment
none required with a multiple baseline design
Control group
Active

Outcomes
Primary outcome [1] 287356 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] 287356 0
baseline and every two weeks of the trial and 3 month follow up
Primary outcome [2] 287357 0
Screen for Child Anxiety Related Emotional Disorders (SCARED, (Birmaher et al., 1999): parent and self-report measures of a broad range of anxiety symptoms in youth.
Timepoint [2] 287357 0
baseline and every two weeks of the trial and 3 month follow up
Primary outcome [3] 287358 0
cortisol levels (morning and evening) assessed via saliva
Timepoint [3] 287358 0
baseline and 8 weeks
Secondary outcome [1] 297978 0
Mood and Feelings Questionnaire (MFQ, (Angold et al., 1995): parent and self-report measure for symptoms of depression in youth. This questionnaire asks how the subject has been feeling and acting lately.
Timepoint [1] 297978 0
baseline and every two weeks of the 8 week trial and 3 month follow up
Secondary outcome [2] 297979 0
Strengths and Difficulties Questionnaire (S&DQ, (Goodman, 1997): a brief behavioural screening measure asking about a range of positive and negative attributes to produce scores on 5 scales- emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems and prosocial behaviour.
Timepoint [2] 297979 0
Baseline, week 8, and 3 month follow-up
Secondary outcome [3] 297980 0
Child Depression Rating Scale (CDRS): a 16-item measure, used for children aged 6-12 years old, measuring the severity of depression. Assessment information is based on interviews with the child and parent
Timepoint [3] 297980 0
Baseline, every two weeks for 8 weeks, and 3 month follow up
Secondary outcome [4] 297981 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 from 1 through 100 that is separated into 10-point sections indicating the child's level of functioning.
Timepoint [4] 297981 0
Baseline, every two weeks for 8 weeks, and 3 month follow up
Secondary outcome [5] 297982 0
Parenting Stress Index (PSI, (Abidin, 1995): a measure of child characteristics, parent characteristics and the parent-child relationship associated with the presence of parenting stress.
Timepoint [5] 297982 0
Baseline, after child has taken micronutrients for 8 weeks and 3 month follow up
Secondary outcome [6] 297983 0
Paediatric Emotional Distress Scale (PEDS, (Saylor, Swenson, Reynolds, & Taylor, 1999) : a brief measure designed to detect elevated symptoms or behaviour in children following a stressful event/trauma.
Timepoint [6] 297983 0
Baseline, after child has taken micronutrients for 8 weeks, and at 3 month follow-up
Secondary outcome [7] 297984 0
Revised Children's Manifest Anxiety Scale (RCMAS, (Reynolds & Richmond, 1978): a self-report measure of yes and no questions assessing anxiety in children.
Timepoint [7] 297984 0
baseline, every 2 weeks for the 8 week trial and 3 month follow up
Secondary outcome [8] 297985 0
Measure Yourself Medical Outcome Profile (MYMOP, (Paterson, 1996): a self-report outcome questionnaire about symptoms, side-effects and well-being based on Paterson (1996).
Timepoint [8] 297985 0
baseline, every 2 weeks for the 8 week trial and 3 month follow up

Eligibility
Key inclusion criteria
1. Participants are between 8-11 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 8 capsules/day).
3. Participants must be able to eat at least a snack two times per day, so that the capsules will not be ingested on an empty stomach.
4. Participants meet criteria for elevated anxiety as assessed by the SCARED. They would also require a CGAS score of at least 50.
Minimum age
8 Years
Maximum age
11 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 participant known to be allergic to the ingredients of the intervention (including ginkgo biloba, germanium sesquioxide, or grape seed) will be excluded.
4. Any known abnormality of mineral metabolism (e.g., Wilson’s disease, haemochromatosis).
5. 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.
6. Participants will be excluded temporarily if they have taken an oral antibiotic in the previous 6 weeks.
7. Any type of nutritional or herbal supplement, known to have a centrally-acting effect, will result in a participant's exclusion. However, participants 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.
7. 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)
the participants will be randomized to one of three start times (1 week, 2 weeks or 3 weeks post baseline). Each participant number (1 thorugh 15) will be assigned to one of three start times, these start times will be concealed in a sealed envelope and opened once the participant has completed baseline and is ready to begin the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
www.randomization.com will be used to randmoize the 15 participants to the three different baselines.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/07/2012
Actual
16/07/2012
Date of last participant enrolment
Anticipated
Actual
2/09/2013
Date of last data collection
Anticipated
Actual
1/01/2014
Sample size
Target
15
Accrual to date
Final
14
Recruitment outside Australia
Country [1] 4367 0
New Zealand
State/province [1] 4367 0

Funding & Sponsors
Funding source category [1] 285457 0
University
Name [1] 285457 0
Department of Psychology, University of Canterbury
Country [1] 285457 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] 284312 0
None
Name [1] 284312 0
Address [1] 284312 0
Country [1] 284312 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287472 0
Upper South A Regional Ethics Committee
Ethics committee address [1] 287472 0
Ethics committee country [1] 287472 0
New Zealand
Date submitted for ethics approval [1] 287472 0
Approval date [1] 287472 0
18/06/2012
Ethics approval number [1] 287472 0
URA/12/05/014

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

Contacts
Principal investigator
Name 34327 0
A/Prof Julia Rucklidge
Address 34327 0
Private Bag 4800
Department of Psychology
University of Canterbury
Christchurch 8140
Country 34327 0
New Zealand
Phone 34327 0
+6433642987
Fax 34327 0
Email 34327 0
[email protected]
Contact person for public queries
Name 17574 0
Assoc. Prof. Julia Rucklidge
Address 17574 0
Dept of Psychology
University of Canterbury
Private bag 4800
Christchurch
8140
Country 17574 0
New Zealand
Phone 17574 0
6433642987 ext 7959
Fax 17574 0
6433642181
Email 17574 0
[email protected]
Contact person for scientific queries
Name 8502 0
Assoc. Prof. Julia Rucklidge
Address 8502 0
Dept of Psychology
University of Canterbury
Private bag 4800
Christchurch
8140
Country 8502 0
New Zealand
Phone 8502 0
6433642987 ext 7959
Fax 8502 0
6433642181
Email 8502 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.