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Trial registered on ANZCTR
Registration number
ACTRN12611000460909
Ethics application status
Approved
Date submitted
2/05/2011
Date registered
4/05/2011
Date last updated
31/03/2014
Type of registration
Retrospectively registered
Titles & IDs
Public title
Investigation into the effect of micronutrients on stress and anxiety post-earthquake: Comparison of two micronutrient formulas
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Scientific title
Investigation into the effect of micronutrients on stress and anxiety post-earthquake: Comparison of two micronutrient formulas
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Secondary ID [1]
260092
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Stress and anxiety resulting from the Christchurch earthquakes
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Condition category
Condition code
Mental Health
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0
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Anxiety
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Alternative and Complementary Medicine
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0
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Other alternative and complementary medicine
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
We will be randomizing participants to one of three conditions: 1) Berocca Performance (oral capsule, 1 a day), a 16 ingredient micronutrient formula, 2) EMPowerplus (4 oral pills once a day) a 36 ingredient micronutrient formula, or 3) EMPoweprlus (8 oral pills - 4 twice a day) for a 4 week period with natural follow up.
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Intervention code [1]
264333
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Treatment: Other
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Comparator / control treatment
Berocca is serving as the comparator treatment as RCTs have already been done on this formula and shown that it is better than placebo in the treatment of stress in normal adults. We are also using two doses of the treatment.
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Control group
Active
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Outcomes
Primary outcome [1]
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Depression, Anxiety and Stress Scale (Lovibond and Lovibond, 1995)
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Assessment method [1]
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Timepoint [1]
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Baseline and every week for 4 weeks plus one month natural follow up
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Primary outcome [2]
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Clinical Global Impression (CGI) of mood, anxiety, stress and energy
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Assessment method [2]
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Timepoint [2]
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4 weeks and one month follow up
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Secondary outcome [1]
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Perceived Stress Scale (PSS): The PSS was designed to assess the degree to which situations in people's lives are appraised as stressful (Cohen et al. 1983).
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Assessment method [1]
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Timepoint [1]
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Baseline and every week for 4 weeks plus one month natural follow up
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Secondary outcome [2]
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Impact of Events Scale: (Weiss & Marmar, 1997). The Impact of Events Scale Revised (IES-R, Weiss & Marmar, 1997) is a 22-item measure of commonly experienced symptoms following a distressing event.
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Assessment method [2]
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Timepoint [2]
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Baseline and every week for 4 weeks plus one month natural follow up
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Eligibility
Key inclusion criteria
Inclusion criteria: Participants must have been in Christchurch at the time of at least one of the major earthquakes (September 4th 2010 or February 22nd 2011). They must be free of psychotropic medications for the trial. Further, they must be over 18 years of age, possess 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 8 capsules/day), and must be able to eat at least a snack twice per day. They must also have at least one score above the cutoffs of the Depression, Anxiety and Stress Scale: Cutoffs have been provided to indicate mild, moderate or severe problems; anything below 13 (for depression), 10 (for anxiety) and 18 (for stress) is considered within the normal to mild range.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Participants will be excluded from the study for any of the following reasons:
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. Pregnant or breastfeeding.
5. Evidence of untreated or unstable thyroid disease (based on interview)
6. Any known abnormality of mineral metabolism (e.g., Wilson’s disease, haemochromatosis).
7. 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.
8. Participants will be excluded temporarily if they have taken an oral antibiotic in the previous 6 weeks.
9. 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.
10. Any subject judged clinically to be at serious risk for suicide or violence in the opinion of the researchers.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This trial cannot be blind as we are comparing two treatments of which one treatment is being given with two different doses. However, once a participant is deemed eligible, they will be randomized to one of the three treatments.
Once a participant is eligible, they are assigned a number - that number is associated with a folder and envelope. The envelope contains the treatment for that number.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will use a computer programme that randomizes patient numbers equally within a specified set - as participants get assigned to the study, they will be given the next allocated number which will be assigned to a specific treatment group.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1 / Phase 2
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
5/05/2011
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Actual
4/04/2011
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Date of last participant enrolment
Anticipated
19/05/2011
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Actual
19/05/2011
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Canterbury
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Address [1]
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Dept of Psychology
Private Bag 4800
Ilam 8140
Christchurch
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Country [1]
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New Zealand
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Primary sponsor type
University
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Name
University of Canterbury
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Address
Dept of Psychology
Private Bag 4800
Ilam 8140
Christchurch
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Human Ethics Committee
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Ethics committee address [1]
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University of Canterbury Private Bag 4800 Christchurch 8140 New Zealand
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
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Approval date [1]
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Ethics approval number [1]
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Ethics committee name [2]
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Human and Disability Ethics Committee
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Ethics committee address [2]
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Ethics committee country [2]
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New Zealand
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Date submitted for ethics approval [2]
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Approval date [2]
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Ethics approval number [2]
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Summary
Brief summary
The purpose of the study is to investigate whether micronutrients can reduce stress and anxiety associated with the Christchurch earthquakes. Two formulas are being compared with one at two different doses.
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Trial website
www.mentalhealthandnutrition.co.nz
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Trial related presentations / publications
Rucklidge, J. J., Andridge, R., Gorman, B., Blampied, N., Gordon, H. & Boggis, A. (2012). Shaken but unstirred? Effects of micronutrients on stress and trauma after an earthquake: RCT evidence comparing formulas and doses. Human Psychopharmacology: Clinical and Experimental, 27(5), 440-454. Rucklidge, J. J., Blampied, N., Gorman, B., Gordon, H., & Sole, E. (in press). Psychological functioning one year after a brief intervention using micronutrients to treat stress and anxiety related to the 2011 Christchurch earthquakes: A naturalistic follow-up. Human Psychopharmacology: Clinical and Experimental.
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Public notes
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Contacts
Principal investigator
Name
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Prof Julia Rucklidge
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Address
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Dept of Psychology, University of Canterbury
Private Bag 4800
Ilam
8140
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Country
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New Zealand
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Phone
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+6433642987
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Fax
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Email
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julia.rucklidge@canterbury.ac.nz
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Contact person for public queries
Name
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Julia Rucklidge
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Address
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Dept of Psychology
University of Canterbury
Private Bag 4800
Christchurch
8140
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Country
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New Zealand
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Phone
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64 3 364 2987 ext 7959
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Fax
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64 3 364 2181
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Email
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julia.rucklidge@canterbury.ac.nz
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Contact person for scientific queries
Name
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Julia Rucklidge
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Address
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Dept of Psychology
University of Canterbury
Private Bag 4800
Christchurch
8140
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Country
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New Zealand
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Phone
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64 3 27 5 384 106
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Fax
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64 3 364 2181
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Email
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julia.rucklidge@canterbury.ac.nz
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No information has been provided regarding IPD availability
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
Source
Title
Year of Publication
DOI
Embase
Shaken but unstirred? Effects of micronutrients on stress and trauma after an earthquake: RCT evidence comparing formulas and doses.
2012
https://dx.doi.org/10.1002/hup.2246
Embase
Psychological functioning 1 year after a brief intervention using micronutrients to treat stress and anxiety related to the 2011 Christchurch earthquakes: A naturalistic follow-up.
2014
https://dx.doi.org/10.1002/hup.2392
N.B. These documents automatically identified may not have been verified by the study sponsor.
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