Trial Review

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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
Scientific title
Investigation into the effect of micronutrients on stress and anxiety post-earthquake: Comparison of two micronutrient formulas
Secondary ID [1] 260092 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress and anxiety resulting from the Christchurch earthquakes 265518 0
Condition category
Condition code
Mental Health 265668 265668 0 0
Anxiety
Alternative and Complementary Medicine 265932 265932 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 264333 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 266447 0
Depression, Anxiety and Stress Scale (Lovibond and Lovibond, 1995)
Timepoint [1] 266447 0
Baseline and every week for 4 weeks plus one month natural follow up
Primary outcome [2] 269091 0
Clinical Global Impression (CGI) of mood, anxiety, stress and energy
Timepoint [2] 269091 0
4 weeks and one month follow up
Secondary outcome [1] 273796 0
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).
Timepoint [1] 273796 0
Baseline and every week for 4 weeks plus one month natural follow up
Secondary outcome [2] 273797 0
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.
Timepoint [2] 273797 0
Baseline and every week for 4 weeks plus one month natural follow up

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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)
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.
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.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/05/2011
Actual
4/04/2011
Date of last participant enrolment
Anticipated
19/05/2011
Actual
19/05/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 3337 0
New Zealand
State/province [1] 3337 0

Funding & Sponsors
Funding source category [1] 264795 0
University
Name [1] 264795 0
University of Canterbury
Country [1] 264795 0
New Zealand
Primary sponsor type
University
Name
University of Canterbury
Address
Dept of Psychology
Private Bag 4800
Ilam 8140
Christchurch
Country
New Zealand
Secondary sponsor category [1] 263907 0
None
Name [1] 263907 0
Address [1] 263907 0
Country [1] 263907 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266768 0
Human Ethics Committee
Ethics committee address [1] 266768 0
Ethics committee country [1] 266768 0
New Zealand
Date submitted for ethics approval [1] 266768 0
Approval date [1] 266768 0
Ethics approval number [1] 266768 0
Ethics committee name [2] 266769 0
Human and Disability Ethics Committee
Ethics committee address [2] 266769 0
Ethics committee country [2] 266769 0
New Zealand
Date submitted for ethics approval [2] 266769 0
Approval date [2] 266769 0
Ethics approval number [2] 266769 0

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

Contacts
Principal investigator
Name 32433 0
Prof Julia Rucklidge
Address 32433 0
Dept of Psychology, University of Canterbury
Private Bag 4800
Ilam
8140
Country 32433 0
New Zealand
Phone 32433 0
+6433642987
Fax 32433 0
Email 32433 0
[email protected]
Contact person for public queries
Name 15680 0
Julia Rucklidge
Address 15680 0
Dept of Psychology
University of Canterbury
Private Bag 4800
Christchurch
8140
Country 15680 0
New Zealand
Phone 15680 0
64 3 364 2987 ext 7959
Fax 15680 0
64 3 364 2181
Email 15680 0
[email protected]
Contact person for scientific queries
Name 6608 0
Julia Rucklidge
Address 6608 0
Dept of Psychology
University of Canterbury
Private Bag 4800
Christchurch
8140
Country 6608 0
New Zealand
Phone 6608 0
64 3 27 5 384 106
Fax 6608 0
64 3 364 2181
Email 6608 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseShaken but unstirred? Effects of micronutrients on stress and trauma after an earthquake: RCT evidence comparing formulas and doses.2012https://dx.doi.org/10.1002/hup.2246
EmbasePsychological functioning 1 year after a brief intervention using micronutrients to treat stress and anxiety related to the 2011 Christchurch earthquakes: A naturalistic follow-up.2014https://dx.doi.org/10.1002/hup.2392
N.B. These documents automatically identified may not have been verified by the study sponsor.