Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001051730
Ethics application status
Approved
Date submitted
18/09/2013
Date registered
20/09/2013
Date last updated
14/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigation into the effect of micronutrients for the maintenance of good health after the Southern Alberta flood:
Comparison of three micronutrient formulas
Scientific title
In people suffering depression or anxiety following the Southern Alberta flood, what are the mental health effects of three different micronutrient formulas?
Secondary ID [1] 283138 0
Nil
Universal Trial Number (UTN)
U1111-1147-5834
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Symptoms of depression 289991 0
Symptoms of anxiety 289992 0
Condition category
Condition code
Mental Health 290373 290373 0 0
Depression
Mental Health 290374 290374 0 0
Anxiety
Alternative and Complementary Medicine 290527 290527 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomized to receive one of three nutrient formulas for six weeks: a single vitamin (Douglas Laboratories vitamin D at 1000 IU/day), a multivitamin formula (Douglas Laboratories B Complex), or a multivitamin/mineral formula (Truehope EMP). All formulas are in capsules or tablets to be consumed orally. Participants will be asked to self-monitor pill consumption and to report it every two weeks for an estimate of adherence.

Following the 6 weeks of randomization, a 6-week extension will be offered in which people may choose whatever formula they will to try -- either to continue with the one they have been taking, or to try one of the others. This 'personal choice extension' will not be a requirement, but for those who choose to participate, the same outcome questionnaires will be presented at the end of the extension period.

Vitamin D ingredients (dose = 1/day):
Vit D 25.0 mcg (1000 IU)

B Complex ingredients (dose = 1/day):
3-Pyridinecarboxamide 50.0 mg
Biotin 300.0 mcg
Folate 400.0 mcg
Intrinsic Factor 20.0 mg
Pantothenic acid 50.0 mg
Riboflavin 20.0 mg
Thiamine 50.0 mg
Vit B12 500.0 mcg
Vit B6 20.0 mg

Truehope EMP ingredients (dose = 4/day):
l-glutamine 10.0 mg
Inositol 10.0 mg
Choline bitartrate 30.0 mg
Phenylalanine 20.0 mg
Biotin 60.0 mcg
Germanium sesquioxide 1.2 mg
Calciium 73.3 mg
Chromium 34.7 mcg
Citrus bioflavonoids 13.3 mg
Copper 0.4 mg
Pantothenic acid 1.2 mg
Folate 80.0 mcg
Ginkgo biloba 2.0 mg
Iodine 11.3 mcg
Iron 0.8 mg
L-methionine 3.3 mg
Magnesium 33.3 mg
Manganese 0.5 mg
Molybdenum 8.0 mcg
Niacin 5.0 mg
Nickel 1.6 mcg
Phosphorus 46.7 mg
Potassium 13.3 mg
Riboflavin 0.8 mg
Selenium 11.3 mcg
Thiamine 1.0 mg
Vanadium 66.3 mcg
Vit A 96.0 mcg (320 IU)
Vit B12 50.0 mcg
vit B6 2.0 mg
Vit C 33.3 mg
Vit D 2.0 mcg (80.0 IU)
Vit E 13.4 mg (20.0 IU)
Vitis vinifera (grape seed) 2.5 mg
Zinc 2.7 mg
Intervention code [1] 287866 0
Treatment: Other
Comparator / control treatment
All three treatments are active, including the single vitamin, but the single vitamin is the primary comparator treatment.
Control group
Active

Outcomes
Primary outcome [1] 290402 0
Modified Clinical Global Impressions (CGI-I; Spearing et al., 1997) The questions ask participants to rate how much they think their mood, anxiety, stress, energy, and sleep have changed since they started the trial, using a 7 point scale from 1 (very much improved) to 7 (very much worse).
Timepoint [1] 290402 0
Following 6 weeks of treatment, again after 12 weeks for those who participate in the extension
Primary outcome [2] 290403 0
The Depression Anxiety and Stress Scale (DASS; Lovibond and Lovibond, 1995b) is a 42-item questionnaire which assesses an individual’s current severity of symptoms relating to depression, anxiety and stress.
Timepoint [2] 290403 0
Baseline and after 6 weeks of treatment, again after 12 weeks for those who participate in the extension
Secondary outcome [1] 304476 0
Impact of event Scale - Revised (IES-R; Weiss & Marmar, 1997)
Timepoint [1] 304476 0
Baseline, and after 6 weeks of treatment, and again after 12 weeks for those who participate in the extension.

Eligibility
Key inclusion criteria
1. Over 18 years of age whose homes were damaged by the Southern Alberta flood. 2. Have at least one score above the cutoffs of the Depression, Anxiety and Stress Scale, as follows: 10 (for depression), 7 (for anxiety) or 14 (for stress). 3. Free of psychiatric medications (defined as having taken none for at least four weeks)
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, MS, narcolepsy),
2. Any serious medical condition,
3. Known to be allergic to the ingredients of the intervention,
4. Pregnant or breastfeeding,
5. Evidence of untreated or unstable thyroid disease,
6. Known abnormality of mineral metabolism (e.g., Wilson’s disease, haemochromatosis),
7. Reporting substance dependence within the previous month.
8. Currently participating in the Pure North health program (a local nutritional program).
9. Judged clinically to be at serious risk for suicide or violence in the opinion of the researchers (based on screening information and the intake interview).

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)
Randomisation will occur at the intake interview, after the participant has been deemed eligible for the study, has signed the consent form, and has completed all baseline questionnaires. A sealed envelope with one of the three conditions will be picked randomly and that participant will then be provided with the formula identified in the envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The envelopes will be grouped in blocks so that in every block an equal number of individuals will be assigned to each of the groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
1. During the 6 week trial, all pills will be provided in plain white pill bottles. The ingredient list will be provided on a separate sheet, but without any brand names or the identity of the product’s company.
2. "Personal choice extension": participants will be invited to try the formula of their choice for an additional 6 weeks of open label ‘personal choice’ extension, during which all pills will be in their proper bottles with their manufacturers’ labels. They will be asked for one additional set of outcome measures at the end of the extension period.
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
The changes from baseline to the end of treatment will be compared between randomized groups using repeated-measures ANCOVA, with the baseline level as the covariate. Change measures assessed at the end of treatment with no baseline will be compared using one-way ANOVA. The differences between treatment groups in these measures will be summarized as the mean differences and 95% confidence intervals generated from the ANCOVA/ANOVA models. Categorical outcomes will be compared between groups using Chi-square tests and will be described using odds ratios and 95% confidence intervals. All analyses will be undertaken on an intention-to-treat (ITT) basis that includes all randomized participants analyzed according to the group to which they were randomized. For those participants not completing the 6 weeks, data from their final assessment will be used to evaluate the change scores. Secondary analyses will be undertaken on all outcomes using the per-protocol (completers) analysis set. All tests will be two tailed and any p values less than 0.05 will be considered statistically significant.

Effect sizes in previous research of B complex and EMP have ranged from medium to large, but based on studies of vitamin D treatment of depression, its effect size may be smaller. Based on these numbers, we will power the study to detect a medium effect size between groups; a sample size of 63 participants per group would be required to detect statistically significant (2-tailed a=0.05) between-group effect sizes of 0.5 or greater with 80% power. These effect sizes approximate minimum clinically significant differences for the primary outcome measures. To accommodate a 10% dropout rate, 70 participants will be recruited for each group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/09/2013
Actual
22/10/2013
Date of last participant enrolment
Anticipated
Actual
20/06/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
210
Accrual to date
Final
56
Recruitment outside Australia
Country [1] 5383 0
Canada
State/province [1] 5383 0
Alberta

Funding & Sponsors
Funding source category [1] 287890 0
University
Name [1] 287890 0
University of Calgary (private donor source)
Country [1] 287890 0
Canada
Primary sponsor type
University
Name
University of Calgary
Address
2500 University Dr. NW
Calgary, AB
T2N 1N4
Country
Canada
Secondary sponsor category [1] 286618 0
University
Name [1] 286618 0
University of Canterbury
Address [1] 286618 0
Department of Psychology
University of Canterbury
Private Bag 4800
Christchurch 8140
Country [1] 286618 0
New Zealand
Other collaborator category [1] 277602 0
Individual
Name [1] 277602 0
Julia J. Rucklidge, PhD
Address [1] 277602 0
Department of Psychology
University of Canterbury
Private Bag 4800
Christchurch 8140
Country [1] 277602 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289831 0
Conjoint Health Research Ethics Board (CHREB)
Ethics committee address [1] 289831 0
Ethics committee country [1] 289831 0
Canada
Date submitted for ethics approval [1] 289831 0
Approval date [1] 289831 0
26/08/2013
Ethics approval number [1] 289831 0
REB13-0550
Ethics committee name [2] 289832 0
Human Ethics Committee
Ethics committee address [2] 289832 0
Ethics committee country [2] 289832 0
New Zealand
Date submitted for ethics approval [2] 289832 0
Approval date [2] 289832 0
02/09/2013
Ethics approval number [2] 289832 0
HEC 2013/79/LR

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

Contacts
Principal investigator
Name 42642 0
Prof Bonnie Kaplan
Address 42642 0
Dept of Paediatrics, Owerko Centre, 3820 - 24 Avenue NW Third Floor, Calgary, AB T3B 2X9 Canada
Country 42642 0
Canada
Phone 42642 0
1-403-441-8467
Fax 42642 0
Email 42642 0
[email protected]
Contact person for public queries
Name 42643 0
Bonnie Kaplan
Address 42643 0
Dept of Paediatrics, Owerko Centre, 3820 - 24 Avenue NW Third Floor, Calgary, AB T3B 2X9 Canada
Country 42643 0
Canada
Phone 42643 0
1-403-441-8467
Fax 42643 0
Email 42643 0
[email protected]
Contact person for scientific queries
Name 42644 0
Bonnie Kaplan
Address 42644 0
Dept of Paediatrics, Owerko Centre, 3820 - 24 Avenue NW Third Floor, Calgary, AB T3B 2X9 Canada
Country 42644 0
Canada
Phone 42644 0
1-403-441-8467
Fax 42644 0
Email 42644 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

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