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Trial registered on ANZCTR


Registration number
ACTRN12618001400257
Ethics application status
Approved
Date submitted
7/08/2018
Date registered
20/08/2018
Date last updated
20/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of Activated B-vitamins compared with Standard B-vitamins in easing stress and fatigue in students.
Scientific title
‘Comparative effectiveness of standard-B-vitamins and activated B-vitamins in easing stress, anxiety and fatigue in higher education students: A Randomised Control Trial’
Secondary ID [1] 295626 0
Nil Known
Universal Trial Number (UTN)
U1111-1217-8611
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Stress 308954 0
Anxiety 308955 0
Fatigue 308956 0
Condition category
Condition code
Mental Health 307854 307854 0 0
Other mental health disorders
Mental Health 308068 308068 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventions will include using activated-B-Vitamin complex as the comparator and standard B-vitamin complex as the active control.

Standard B-Vitamin "Mega B complex" - Active control
Listed with the Therapeutic Goods Administration Aust L 196115.
Description: Herbs of Gold Mega B Complex contains therapeutic amounts of all B vitamins including B1, B2, B3, B5, B6, B12, biotin and folic acid, as well as choline and inositol (Herbs of Gold, 2017).
Ingredients: Each Capsule contains; Biotin 100micrograms, Calcium pantothenate 75mg, Choline bitartrate 50mg, Cyanocobalamin 500 micrograms, folic acid 500 micrograms, Inositol 50mg, Nicotinamide 100mg, Nicotinic acid 10mg, pyridoxine hydrochloride 100mg, Riboflavin 100mg, Thiamine hydrochloride 100mg

"Activated B-vitamin Complex" - Comparator
Listed with the Therapeutic Goods Administration Aust L 284123.
Description: Herbs of Gold Activated B Complex contains activated B vitamins, including B2, B6, methyl-folate (folate) and mecobalamin (B12), to help support healthy energy levels and assist in the maintenance of general wellbeing (Herbs of Gold, 2017).
Ingredients: Each tablet contains Calcium pantothenate 25mg, levomefolate calcium 433.1 microgram, mecobalamin (co-methylcobalamin) 400 microgram, Nicotinamide 25mg, pyridoxal 5-phosphate monohydrate 25mg, Riboflavin sodium phosphate 25mg, Thiamine hydrochloride 25mg.

Washout period details – Trial in its entirely will be conducted over a four-week period. This will include a one-week wash out period and a three-week intervention period.

Dosage for both Activated B-vitamin and Standard B-vitamin will be 1 capsule or tablet respectively, daily with food over a 3 week period (21 days).

Participants do have currently access to both interventions as they are widely available for sale in health food shops and pharmacy. Participants will be provided with the interventions for free during the trial period. Participants will continue to have access to both vitamins activated and standard post trial.

Adherence: Adherence will be observed through study personnel. All supplements will be return at the conclusion of the 3 weeks and tablets counted to assess adherence.
Intervention code [1] 301934 0
Treatment: Drugs
Comparator / control treatment
This Randomised Control Trial is a comparative study and will be using the active control of standard B-vitamin.

Comparator: Activated B-Vitamins
Dose: 1 tablet daily, with food.
Duration: 3 weeks
Mode of administration: oral

Active Control: 'Mega B Complex',
Dose: 1 capsule, daily with food
Duration: 3 weeks
Mode of Administration: Oral
Control group
Active

Outcomes
Primary outcome [1] 306834 0
Primary Outcome
Stress according to the Depression Anxiety Stress Scale (DASS 21).
Timepoint [1] 306834 0
Participant will contact principal investigator (CD) who will assess eligibility. If participants are eligible, consent will be sought, and a 1 week washout period will commence (week 1 - washout).

Week 2 - baseline measures will be taken, including DASS21 & FSS. Randomisation will occur and an intervention will be given for a 3 week period.

Week 4 – Follow up measurements will be taken at the end of the week four, which will include DASS21 and FSS.

Time-points for assessment will be beginning of week two (baseline), and at the end of week four (follow-up).
There will be two assessment time points.
1. Post week 1 wash out, baseline assessment will be conducted at the beginning of week two.
2. Follow up assessment will occur at the end of week 4, post the 3-week of intervention.
Secondary outcome [1] 349846 0
1. Fatigue Severity Scale (FSS)
Timepoint [1] 349846 0
Intervention will be continued for three weeks.
Week 2 - intervention
week 3 -intervention
Week 4 - intervention

Follow-up data will be collected at the end of the 4th week, this will include DASS21 and FSS.

There will be two assessment time points.
3. Post week 1 wash out, baseline assessment will be conducted at the beginning of week two.
4. Follow up assessment will occur at the end of week 4, post the 3-week of intervention.
Secondary outcome [2] 350820 0
2. Feasibility outcomes:
a. Recruitment
b. Retention and adherence of participants
Timepoint [2] 350820 0
There will be one assessment time points for feasibility.

Feasibility outcomes will be measured at week 4 only and determined by recruitment numbers, retention and adherence of participants.

Eligibility
Key inclusion criteria
A student enrolled at Endeavour College of Natural Health Sydney campus
Aged over 18 years
Willing to abstain from vitamins regime for one week
Time availability to attend two one-hour data collection session
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnancy
Known allergies to B group vitamins
Not willing to abstain from vitamins regime for one week

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation sequence will be concealed from the research team. It will be generated independently in blocks of 50, by a company in the United Kingdom, Sealed Envelope. Randomisation will be requested and applied in real time at week one of the trial. The randomisation allocation sequence will be concealed from the research team.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of participants to one of two arms: (1) activated B complex or (2) standard B complex. This will occur through the private company in the UK Sealed Envelope. A computer-generated randomisation sequence in a block of 50 will be generated for this study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
This RCT will include blinding in two of four domains. The researchers will be blind to randomisation sequence. Participants may be aware of their allocated group due to different tablet appearances. The researchers will be aware of group allocation as she will be administering the interventions. The statistical analyses will be undertaken blind to group allocation.
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
It was estimated that 60 participants per group would be required to detect a clinically meaningful difference between groups. The estimated sample size was based on a difference between groups of 4 or more points on the stress items of the DASS21, with 80% power and a significance level of a =0.05. This calculation was based on previous studies investigating B-vitamins and reported treatment effect sizes on the primary outcome measure (DASS 21) (Kaplan et al., 2015). Based on attrition rates from other studies, we estimated a 10% loss to attrition and calculated the necessary sample size at 132.

Data will be coded and entered onto statistical software STATA (StataCorp LLC, 2018) and statistically analysed blind to group assignment. There will be no interim analyses. Analyses will be performed on an intention-to-treat basis, and data from participants who withdraw or are withdrawn will be analysed according to their group of random assignment. Missing end point data will be imputed with the last observation carried forward method.

Analysis of covariance (ANCOVA) will be used to investigate mean differences between groups at three weeks and control baseline variability (means with large standard deviations).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/08/2018
Actual
Date of last participant enrolment
Anticipated
1/10/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
132
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 23507 0
2000 - Haymarket

Funding & Sponsors
Funding source category [1] 300204 0
University
Name [1] 300204 0
Endeavour College of Natural Health
Country [1] 300204 0
Australia
Funding source category [2] 300376 0
Commercial sector/Industry
Name [2] 300376 0
Vita Life Sciences
Country [2] 300376 0
Australia
Primary sponsor type
University
Name
Endeavour College of Natural Health
Address
815-825 George St
HAYMARKET NSW 2000
Country
Australia
Secondary sponsor category [1] 299767 0
None
Name [1] 299767 0
Address [1] 299767 0
Country [1] 299767 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301030 0
Endeavour College of Natural Health Human Research Ethics Committee.
Ethics committee address [1] 301030 0
Ethics committee country [1] 301030 0
Australia
Date submitted for ethics approval [1] 301030 0
05/06/2018
Approval date [1] 301030 0
08/08/2018
Ethics approval number [1] 301030 0
20180808

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

Contacts
Principal investigator
Name 85646 0
Miss Cassie Davenport
Address 85646 0
Miss Cassie Davenport
Endeavour College of Natural Health - Honours Student
815- 825 George St
HAYMARKET NSW AUSTRALIA 2000
Country 85646 0
Australia
Phone 85646 0
+61414 362 175
Fax 85646 0
Email 85646 0
[email protected]
Contact person for public queries
Name 85647 0
Susan Arentz
Address 85647 0
Dr Susan Arentz – Head of Department of Naturopathy
Endeavour College of Natural Health
815- 825 George St
HAYMARKET NSW AUSTRALIA 2000
Country 85647 0
Australia
Phone 85647 0
+61 02 8204 7709
Fax 85647 0
Email 85647 0
[email protected]
Contact person for scientific queries
Name 85648 0
Amie Steel
Address 85648 0
Dr Amie Steel – Associate Director Research
Endeavour College of Natural health.
Level 2/269 Wickham St,
Fortitude Valley QLD 4006
Country 85648 0
Australia
Phone 85648 0
+61 07 3253 9523
Fax 85648 0
Email 85648 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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