Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000759190p
Ethics application status
Submitted, not yet approved
Date submitted
30/04/2019
Date registered
22/05/2019
Date last updated
27/05/2020
Date data sharing statement initially provided
22/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigation into the effect of micronutrients on stress and anxiety following the Christchurch Mosque shootings
Scientific title
Investigation into the effect of micronutrients on stress and anxiety following the Christchurch Mosque shootings: an open label study
Secondary ID [1] 298075 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stress 312580 0
anxiety 312649 0
Condition category
Condition code
Mental Health 311092 311092 0 0
Anxiety
Alternative and Complementary Medicine 311147 311147 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is an open label pre post design whereby we will give micronutrients for 6 weeks to people who have been victims of the mosque shooting in Christchurch.
Participants will be asked to consume 3 pills twice a day. Total dose per day is:
Vitamin A (as retinyl palmitate) 4000.0 IU
Vitamin C (as ascorbic acid) 300.0 mg
Vitamin D (as cholecalciferol) 3000.0 IU
Vitamin E (as d-alpha tocopheryl succinate) 70 IU
Vitamin K1 (as phylloquinone & menaquinone-7) 120.0 mcg
Thiamin (as thiamin mononitrate) 54.0 mg
Riboflavin 16.0 mg
Niacin (as niacinamide) 52.0 mg
Vitamin B6 (as pyridoxine hydrochloride) 48.0 mg
Folate (as folic acid & L-methylfolate calcium) 800.0 mcg
Vitamin B12 (as methylcobalamin) 336.0 mcg
Biotin 636.0 mcg
Pantothenic acid (as d-calcium pantothenate) 28.0 mg
Calcium (as chelate) 606.0 mg
Iron (as chelate) – for women 27.0 mg
Iron (as chelate) – for men 8.0 mg
Phosphorus (as chelate) 386.0 mg
Iodine (as chelate) 240.0 mcg
Magnesium (as chelate) 274.0 mg
Zinc (as chelate) 22 mg
Selenium (as chelate) 92.0 mcg
Copper (as chelate) 3.2 mg
Manganese (as chelate) 4.4 mg
Chromium (as chelate) 286 mcg
Molybdenum (as chelate) 66.0 mcg
Potassium (as chelate) 110.0 mg
Other ingredients (doses not provided as proprietary blend): Choline, coenzyme Q10, beta sitosterol, tocopherol, Mineral wax, Spirulina, Larch arabinogalactan, Inositol, Rhodiola rosea root extract, alpha lipoic extract, bamboo shoot extract, Astragalus root extract, Royal jelly, Grape seed extract, Ginkgo biloba leaf extract, Boron (as chelate), Vanadium (as chelate), Lithium orotate (as chelate), Nickel (as chelate)vegetarian capsule, microcrystalline cellulose, magnesium stearate, silicon dioxide, Extra for men: saw palmetto fruit extract

Participants will be asked to tell us number of missed doses every two weeks and also after 4 weeks, how many pills are remaining in the bottle.
Intervention code [1] 314306 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319874 0
Clinical Global Impression - I (CGI-I) - modified for completion by participants - documenting the number of responders to the treatment
Timepoint [1] 319874 0
2 weeks, 4 weeks, 6 weeks (primary endpoint), 6 months (post enrollment), 12 months (post enrollment). The data will also be summarized as number of responders at 6 weeks based on a 1 or 2 on the CGI-I.
Primary outcome [2] 319875 0
Depression, Anxiety and Stress Scale (Lovibond and Lovibond, 1995) - DASS-21
Timepoint [2] 319875 0
baseline, 2 weeks, 4 weeks, 6 weeks (primary endpoint), 6 months (post enrollment), 12 months (post enrollment). We will also report on number who fall into the nonclinical range at 6 weeks.
Secondary outcome [1] 369755 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 [1] 369755 0
baseline, 2 weeks, 4 weeks, 6 weeks, 6 months (post enrollment), 12 months (post enrollment).
Secondary outcome [2] 369887 0
side effects - checklist of symptoms commonly experienced when taking capsules. We have modified the Antidepressant Side-Effects Checklist for use with micronutrients (Uher et al., 2016).
Side effects observed as a result of taking this micronutrient formula are:
Frequent: change in urine colour (a fluorescent yellow colour due to riboflavin).
Infrequent: headache, loose stools, nausea.
Rare: flatulence, diarrhoea, stomach ache, vomiting.
Timepoint [2] 369887 0
baseline, 2 weeks, 4 weeks, 6 weeks

Eligibility
Key inclusion criteria
Inclusion criteria: Participants must be a victim of the mosque shooting – either present in one of the mosques or know someone who was in the mosque. 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 6 capsules/day), and must be able to eat at least a snack twice per day. They must self identify as struggling with psychological symptoms as a consequence of the Christchurch events.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: 1) Neurological disorder involving brain or other central function (e.g., epilepsy, MS, narcolepsy), 2) Any serious medical condition, 3) Any participant known to be allergic to the ingredients of the intervention, 4) Evidence of untreated or unstable thyroid disease, 5) Any known abnormality of mineral metabolism (e.g., Wilson’s disease, haemochromatosis), 6) evidence of substance dependence within the previous month, 7) Any participant 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)
none
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This is a simple pre to post design -t-tests on primary outcomes will be sufficient to determine change. Results will also be reported in terms of number of responders (1 or 2 on the CGI-I at 6 weeks) and number of people who go into remission based on DASS scores and IES-R scores. Moderators will also be investigated with regression including demographic variables and level of distress before starting the trial.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Challenging political environment making it impossible to run research
Date of first participant enrolment
Anticipated
27/05/2019
Actual
Date of last participant enrolment
Anticipated
31/08/2019
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 21437 0
New Zealand
State/province [1] 21437 0

Funding & Sponsors
Funding source category [1] 302605 0
Charities/Societies/Foundations
Name [1] 302605 0
University of Canterbury Foundation
Country [1] 302605 0
New Zealand
Primary sponsor type
Individual
Name
Julia Rucklidge
Address
Department of Psychology
University of Canterbury
Private Bag 4800
Christchurch
8140
Country
New Zealand
Secondary sponsor category [1] 302518 0
None
Name [1] 302518 0
Address [1] 302518 0
Country [1] 302518 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303240 0
University of Canterbury Human Ethics Committee
Ethics committee address [1] 303240 0
Ethics committee country [1] 303240 0
New Zealand
Date submitted for ethics approval [1] 303240 0
29/04/2019
Approval date [1] 303240 0
Ethics approval number [1] 303240 0

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

Contacts
Principal investigator
Name 92970 0
Prof Julia J Rucklidge
Address 92970 0
Department of Psychology
University of Canterbury
Private Bag 4800
Christchurch
8140
Country 92970 0
New Zealand
Phone 92970 0
64275384106
Fax 92970 0
Email 92970 0
[email protected]
Contact person for public queries
Name 92971 0
Julia J Rucklidge
Address 92971 0
Department of Psychology
University of Canterbury
Private Bag 4800
Christchurch
8140
Country 92971 0
New Zealand
Phone 92971 0
64275384106
Fax 92971 0
Email 92971 0
[email protected]
Contact person for scientific queries
Name 92972 0
Julia J Rucklidge
Address 92972 0
Department of Psychology
University of Canterbury
Private Bag 4800
Christchurch
8140
Country 92972 0
New Zealand
Phone 92972 0
64275384106
Fax 92972 0
Email 92972 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
baseline, 2 weeks, 4 weeks, 6 weeks, 6 months, 12 months
When will data be available (start and end dates)?
Once we have analyzed and published the study
no end date
Available to whom?
To researchers who request it and have a valid question to answer based on our data
Available for what types of analyses?
meta-analyses
How or where can data be obtained?
Via the primary investigator


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.