Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000364774
Ethics application status
Approved
Date submitted
27/03/2013
Date registered
5/04/2013
Date last updated
30/01/2019
Date data sharing statement initially provided
30/01/2019
Date results provided
30/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigation into the effect of a micronutrient formula on symptoms of insomnia
Scientific title
Investigation into the effect of a micronutrient formula, on symptoms of insomnia, in an adult population, a pilot study with multiple baseline design.
Secondary ID [1] 282173 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 288684 0
Condition category
Condition code
Mental Health 289032 289032 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention is supplementation with a micronutrient formula distributed by Optimus nutraceuticals. The brand name of the micronutrient formula is "Daily Self Defense". The micronutrient formula will be taken in capsule form, at a dose of 6 capsules per day (two equal doses of 3) during the 8 week treatment phase. Adherence to taking the capsules will be monitored in the daily sleep diary completed by participants where they will fill out a question about how many capsules they took that day.
The ingredients contained in a 6 capsule dose are as follows: Vitamin A (as retinyl palmitate)4000 IU, Vitamin C (as ascorbic acid) 300 mg, Vitamin D (as cholecalciferol) 3000 IU, Vitamin E (as d-alpha tocopheryl succinate) 261.9 IU, Vitamin K1 (as phylloquinone) 90 mcg, Vitamin K2 (as menaquinone-7) 30 mcg, Thiamin (as thiamin mononitrate)60 mg, Riboflavin 16 mg, Niacin (as niacinamide)52 mg, Vitamin B6 (as pyridoxine hydrochloride) 60 mg, Folate (as folic acid) 400 mcg, Folate (as L-methylfolate calcium) 400 mcg, Vitamin B12 (as methylcobalamin) 400 mcg, Biotin 378 mcg, Pantothenic acid (as d-calcium pantothenate 30 mg, Calcium (as chelate) 485 mg, Iron (as chelate) 18 mg, Phosphorus (as chelate) 309.1 mg, Iodine (as chelate) 240 mcg, Magnesium (as chelate) 220.8 mg, Zinc (as chelate) 17.7 mg, Selenium (as chelate) 75 mcg, Copper (as chelate) 2.6 mg, Manganese (as chelate) 3.5 mg, Chromium (as chelate) 229.8 mcg, Molybdenum (as chelate) 52.8 mcg, Potassium (as chelate) 88.3 mg, Choline bitartrate 172.2 mg, Shilajit 75.0 mg, Spirulina 66 mg, Larch arabinogalactan 66 mg, Inositol 57.4 mg, Rhodiola rosea root extract 40 mg, Astragalus root extract 36 mg, Royal jelly 3X 24 mg, Grape seed extract 14.4 mg, Ginkgo biloba leaf extract 11.5 mg, Germanium sesquioxide (as chelate)7.6 mg, Boron (as chelate) 883.2 mcg, Vanadium (as chelate) 439.4 mcg, Lithium orotate (as chelate) 368.2 mcg, Nickel (as chelate) 11.0 mcg, Cellulose 331.2 mg, Glycine 270 mg, Citric acid 160.9 mg, Magnesium stearate 144 mg, Silicon dioxide 120 mg
Intervention code [1] 286782 0
Treatment: Other
Comparator / control treatment
Intervention is compared to a baseline phase during which measurements are taken but there is no intervention. Participants are randomly assigned to different baseline lengths of 1, 2 or 3 weeks.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289146 0
The Pittsburgh Insomnia Rating Scale (PIRS) -a 65 item self report instrument designed to assess severity of insomnia.
Timepoint [1] 289146 0
To be completed at the start of the study, and then weekly throughout baseline and intervention phases.
Primary outcome [2] 289148 0
Consensus Daily Sleep Diary- collects data about sleep each morning for the previous night, including sleep onset latency, number of awakenings, sleep efficiency.
Timepoint [2] 289148 0
To be completed daily from start of study until end of treatment phase.
Primary outcome [3] 289160 0
Clinical Global Impression - Improvement (CGI-I), patient rated - after the randomized baseline phase and end of study
Timepoint [3] 289160 0
On completion of the 8 week treatment phase - the CGI will be used to determine what percentage of participants see themselves as much to very much improved in their sleep since starting the micronutrients.
Secondary outcome [1] 301925 0
The Depression, Anxiety and Stress scale (DASS) will also be completed during the study.
Timepoint [1] 301925 0
Participants will complete the DASS at the start of the study and then weekly throughout baseline and intervention phases.

Eligibility
Key inclusion criteria
Participants must be 18 years or over, be classified as having a diagnosis of 'insomnia' according to the Pittsburgh Insomnia Symptom Questionnaire which they complete during the screening process, and scores in the 'moderate' or 'severe' range for insomnia symptoms on the Piitsburgh Insomnia Rating Scale.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants must not be taking psychotropic medciations (eg antidepressants, anxiolytics) or prescribed sleep medications. They must not be pregnant or breastfeeding, and must not have a child two years or under. They must not have sleep apnoea. They will be asked to not take any other products for assisting with sleep during the course of the trial.

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)
Allocation to the three different baseline groups is randomised.
The randomisation was done using a computer program, and a research assistant other than the researcher placed each participant's baseline allocation number into a sealed envelope to conceal it from the researcher and participant until confirmation of study participation. A tthis point, the envelopw is opened such tha tthe individual and investigator are aware which baseline period that individual was randomized to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software www.randomization.com.
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
Efficacy
Statistical methods / analysis
The results of each case will be looked at using modified Brinley plots to examine each participants baseline measures and then response as the supplement is introduced. Two tailed t- tests will be used to check for significant change across time comparing baseline scores with treatment scores.
The sample size of 15 participants was determined from previous pilot studies using micronutrients, whereby 15 participants was an adequate number to show significant change from pre to post measurements. Our experience with these micronutrients is that they usually have a large effect size, and so 15 is an adequate number to show this change in a pilot study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/02/2013
Actual
15/02/2013
Date of last participant enrolment
Anticipated
2/09/2013
Actual
2/09/2013
Date of last data collection
Anticipated
Actual
28/12/2013
Sample size
Target
15
Accrual to date
Final
17
Recruitment outside Australia
Country [1] 4952 0
New Zealand
State/province [1] 4952 0

Funding & Sponsors
Funding source category [1] 286944 0
University
Name [1] 286944 0
The University of Canterbury - The costs of the study are coming from research grants allocated for a Master's project through the university.
Country [1] 286944 0
New Zealand
Primary sponsor type
University
Name
University of Canterbury
Address
Department of Psychology
University of Canerbury
Private Bag 4800
Ilam 8140
Christchurch
Country
New Zealand
Secondary sponsor category [1] 285729 0
None
Name [1] 285729 0




Address [1] 285729 0
Country [1] 285729 0
Other collaborator category [1] 277335 0
Individual
Name [1] 277335 0
Assoc Prof Julia Rucklidge
Address [1] 277335 0
Department of Psychology
University of Canterbury
Private Bag 4800
Ilam 8140
Christchurch
Country [1] 277335 0
New Zealand
Other collaborator category [2] 277336 0
Individual
Name [2] 277336 0
Assoc Prof Neville Blampied
Address [2] 277336 0
Department of Psychology
University of Canerbury
Private Bag 4800
Ilam 8140
Christchurch
Country [2] 277336 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288996 0
Human Ethics Committee
Ethics committee address [1] 288996 0
Ethics committee country [1] 288996 0
New Zealand
Date submitted for ethics approval [1] 288996 0
12/11/2012
Approval date [1] 288996 0
12/12/2012
Ethics approval number [1] 288996 0
HEC 2012/169

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

Contacts
Principal investigator
Name 38706 0
A/Prof Julia Rucklidge
Address 38706 0
Department of Psychology
University of Canterbury
Private Bag 4800
Christchurch 8140
New Zealand
Country 38706 0
New Zealand
Phone 38706 0
+64 3 3642987 ext7959
Fax 38706 0
Email 38706 0
[email protected]
Contact person for public queries
Name 38707 0
Julia Rucklidge
Address 38707 0
Department of Psychology
University of Canterbury Private Bag 4800
Christchurch 8140
New Zealand
Country 38707 0
New Zealand
Phone 38707 0
+64 3 3642987 ext 7959
Fax 38707 0
Email 38707 0
[email protected]
Contact person for scientific queries
Name 38708 0
Julia Rucklidge
Address 38708 0
Department of Psychology
University of Canterbury
Private Bag 4800
Christchurch 8140
New Zealand
Country 38708 0
New Zealand
Phone 38708 0
+64 3 3642987 ext 7191
Fax 38708 0
Email 38708 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.