Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001026415
Ethics application status
Approved
Date submitted
4/07/2016
Date registered
3/08/2016
Date last updated
28/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effects of a micronutrient formula on insomnia in teachers
Scientific title
Investigating the effects of a micronutrient formula on insomnia in teachers: a multiple-baseline design
Secondary ID [1] 289533 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 299243 0
Condition category
Condition code
Mental Health 299256 299256 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention is supplementation with a micronutrient formula. All participants will receive the micronutrient formula for 8 weeks. The brand name of the micronutrient formula is EMPowerplus (EMP+). The micronutrient formula will be taken in capsule form, at a dose of 8 capsules per day (two equal doses of 4), during the 8 week intervention phase. Adherence to taking the capsules will be monitored through face to face meetings with the participant and researcher where participants will bring their capsules in, and pills will be counted by the researcher.
The ingredients contained in an 8 capsule dose are as follows: Vitamin A (as retinal palmitate) 3072 IU, Vitamin C (as ascorbic acid) 320mg, Vitamin D (as cholecalciferol) 768 IU, Vitamin E (as d-alpha tocopheryl succinate) 192 IU, Thiamin (as thiamin mononitrate) 9.6 mg, Riboflavin 7.2 mg, Niacin (as niacin amide) 48 mg, Vitamin B6 (as pyridoxine hydrochloride) 19.2 mg, Folic acid 768 mcg, Vitamin B12 (as methylcobalamin) 480mcg, Biotin 576 mpg, Pantothenic acid (as calcium pantothenate) 11.52 mg, Calcium (as chelate) 704 mg, Iron (as chelate) 7.328 mg, Phosphorus (as chelate) 448 mg, Iodine (from Pacific kelp) 108.8 mcg, Magnesium (as chelate) 320 mg, Zinc (as chelate) 25.6 mg, Selenium (as chelate) 108.8 mcg, Copper (as chelate) 3.84 mg, Manganese (as chelate) 5.12 mg, Chromium (as chelate) 332.8 mcg, Molybdenum (as chelate) 76.8 msg, Potassium (as chelate) 128 mg.
Intervention code [1] 295127 0
Treatment: Other
Comparator / control treatment
Intervention is compared to baseline and placebo phases during which measurements are taken. All participants will undergo a 1 week baseline phase. Participants will then be randomly assigned to different placebo lengths of 5, 9, or 14 days, before they enter the micronutrient phase.
The ingredients contained in an 8 capsule dose of placebo are as follows: Fiber Acacia Gum 2400mg, Maltodextrin 3167.2mg, Cocoa Powder 32mg, Riboflavin Powder 0.8mg.
Control group
Placebo

Outcomes
Primary outcome [1] 298737 0
The Pittsburgh Insomnia Rating Scale-20 (PIRS-20) - a 20 item self-report instrument designed to assess severity of insomnia.
Timepoint [1] 298737 0
Primary outcome 1 completed at weeks 4 and 10 of the micronutrient phase and at follow-up 3 months post end of the micronutrient phase.
Primary outcome [2] 298738 0
The Expanded Consensus Sleep Diary for Morning (CSD-M) - collects data about sleep each morning for the previous night, including sleep onset latency, number of awakenings, and sleep efficiency.
Timepoint [2] 298738 0
To be completed daily from the start of study until end of intervention phase.
Secondary outcome [1] 325106 0
The Depression, Anxiety, and Stress Scale - 21 (DASS-21) will also be completed during the study.
Timepoint [1] 325106 0
Participants will complete the DASS-21 at the start and end of baseline, as well as during the placebo phases (time points 5, 9, and 14 days), and biweekly once the micronutrient phase has begun until the end of the intervention, and then at 3 month follow up.
Secondary outcome [2] 325107 0
Maslach Burnout Inventory Educators Survey (MBI-ES) - The MBI-ES will also be completed during the study to assess the two core burnout dimensions of emotional exhaustion and cynicism.
Timepoint [2] 325107 0
Participants will complete the MBI-ES once at the beginning of baseline and once at the end of intervention.

Eligibility
Key inclusion criteria
Participants must be teachers 18 years or over working in earthquake affected schools, and must be registered and have at least 2 years experience working full time. They must meet the criteria of 'insomnia' according to the Pittsburgh Insomnia Symptom Questionnaire which they complete during the screening process, and have scores in the 'moderate' or 'severe' range for insomnia symptoms on the Pittsburgh Insomnia Rating Scale -20.
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 medications (e.g., antidepressants, anxiolytics) or prescribed sleep medications. They must not be pregnant or breastfeeding, or intend to attempt to conceive in the near future, and must not have a child 2 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 baseline groups is randomised. The randomisation will be done using a computer programme, and a research assistant other than the researcher will place each participants baseline allocation number into a sealed opaque envelope to conceal it from the researcher and participant.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation using a randomisation table using computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Multiple Baseline Design
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/08/2016
Actual
16/09/2016
Date of last participant enrolment
Anticipated
Actual
9/10/2016
Date of last data collection
Anticipated
Actual
25/12/2016
Sample size
Target
15
Accrual to date
Final
17
Recruitment outside Australia
Country [1] 7984 0
New Zealand
State/province [1] 7984 0
Canterbury

Funding & Sponsors
Funding source category [1] 293912 0
University
Name [1] 293912 0
The University of Canterbury - The cost of the study are coming from research grants allocated for a Master's project through the university
Country [1] 293912 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] 292738 0
None
Name [1] 292738 0
Nil
Address [1] 292738 0
Nil
Country [1] 292738 0
Other collaborator category [1] 279048 0
Individual
Name [1] 279048 0
Professor Neville Blampied
Address [1] 279048 0
Department of Psychology
University of Canerbury
Private Bag 4800
Ilam 8140
Christchurch
Country [1] 279048 0
New Zealand
Other collaborator category [2] 279049 0
Individual
Name [2] 279049 0
Professor Julia Rucklidge
Address [2] 279049 0
Department of Psychology
University of Canerbury
Private Bag 4800
Ilam 8140
Christchurch
Country [2] 279049 0
New Zealand
Other collaborator category [3] 279050 0
Individual
Name [3] 279050 0
Associate Professor Kathleen Liberty
Address [3] 279050 0
College of Education,
Health and Human Development
University of Canterbury
Private Bag 4800
Ilam 8041
Christchurch
Country [3] 279050 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295333 0
University of Canterbury Human Ethics Committee
Ethics committee address [1] 295333 0
Ethics committee country [1] 295333 0
New Zealand
Date submitted for ethics approval [1] 295333 0
10/06/2016
Approval date [1] 295333 0
02/08/2016
Ethics approval number [1] 295333 0

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

Contacts
Principal investigator
Name 66894 0
Miss Alison Carley
Address 66894 0
Department of Psychology
University of Canterbury
Private Bag 4800
Christchurch 8140
New Zealand
Country 66894 0
New Zealand
Phone 66894 0
+64 27 3754496
Fax 66894 0
Email 66894 0
[email protected]
Contact person for public queries
Name 66895 0
Neville Blampied
Address 66895 0
Department of Psychology
University of Canerbury
Private Bag 4800
Ilam 8140
Christchurch
Country 66895 0
New Zealand
Phone 66895 0
+64 3 3642987 ext6199
Fax 66895 0
Email 66895 0
[email protected]
Contact person for scientific queries
Name 66896 0
Neville Blampied
Address 66896 0
Department of Psychology
University of Canerbury
Private Bag 4800
Ilam 8140
Christchurch
Country 66896 0
New Zealand
Phone 66896 0
+64 3 3642987 ext6199
Fax 66896 0
Email 66896 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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