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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.
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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’
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Secondary ID [1]
295626
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Nil Known
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Universal Trial Number (UTN)
U1111-1217-8611
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Trial acronym
N/A
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Linked study record
N/A
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Health condition
Health condition(s) or problem(s) studied:
Stress
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Anxiety
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Fatigue
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Condition category
Condition code
Mental Health
307854
307854
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0
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Other mental health disorders
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Mental Health
308068
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0
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Anxiety
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
301934
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Treatment: Drugs
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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
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Control group
Active
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Outcomes
Primary outcome [1]
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Primary Outcome
Stress according to the Depression Anxiety Stress Scale (DASS 21).
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Assessment method [1]
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Timepoint [1]
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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.
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Secondary outcome [1]
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1. Fatigue Severity Scale (FSS)
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Assessment method [1]
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Timepoint [1]
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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.
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Secondary outcome [2]
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2. Feasibility outcomes:
a. Recruitment
b. Retention and adherence of participants
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Assessment method [2]
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Timepoint [2]
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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.
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
Pregnancy
Known allergies to B group vitamins
Not willing to abstain from vitamins regime for one week
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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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.
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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.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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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.
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Phase
Phase 4
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Type of endpoint/s
Efficacy
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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).
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
20/08/2018
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Actual
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Date of last participant enrolment
Anticipated
1/10/2018
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
132
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment postcode(s) [1]
23507
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2000 - Haymarket
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Endeavour College of Natural Health
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Address [1]
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815-825 George St
HAYMARKET NSW 2000
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Country [1]
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Australia
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Funding source category [2]
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Commercial sector/Industry
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Name [2]
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Vita Life Sciences
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Address [2]
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Herbs of Gold
1/102 Bath Rd
KIRRAWEE NSW 2232
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Country [2]
300376
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Australia
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Primary sponsor type
University
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Name
Endeavour College of Natural Health
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Address
815-825 George St
HAYMARKET NSW 2000
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
299767
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Country [1]
299767
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Endeavour College of Natural Health Human Research Ethics Committee.
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Ethics committee address [1]
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Level 2/269 Wickham St,
Fortitude Valley QLD 4006
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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05/06/2018
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Approval date [1]
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08/08/2018
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Ethics approval number [1]
301030
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20180808
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Summary
Brief summary
Vitamin supplement use is prevalent in Australia. B-vitamin supplements have been shown to reduce symptoms associated with stress and anxiety, and new 'activated' B vitamins are claimed to achieve this clinical outcome with greater efficiency. However, despite the increased costs, there are no clinical data to support this health claim. Tertiary students are at high risk of increased stress. This randomised control trial will compare the effectiveness of activated B-complex vitamins against standard-B-complex vitamins on stress, fatigue and anxiety outcomes in tertiary students. Participants will be recruited from the Sydney campus of Endeavour College of Natural Health and randomly assigned to one of two groups; 1.Activated-B or 2.Standard-B. The study duration will be four weeks, including a pre-treatment week and baseline data collection and treatment for three weeks. The primary outcome measure will be the validated instrument DASS 21; secondary outcomes will include the Fatigue Severity Scale and feasbility markers; recruitment, retention and adherence of participants.
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Trial website
N/A
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Trial related presentations / publications
N/A
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Public notes
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Contacts
Principal investigator
Name
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Miss Cassie Davenport
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Address
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Miss Cassie Davenport
Endeavour College of Natural Health - Honours Student
815- 825 George St
HAYMARKET NSW AUSTRALIA 2000
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Country
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Australia
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Phone
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+61414 362 175
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Susan Arentz
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Address
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Dr Susan Arentz – Head of Department of Naturopathy
Endeavour College of Natural Health
815- 825 George St
HAYMARKET NSW AUSTRALIA 2000
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Country
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Australia
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Phone
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+61 02 8204 7709
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Amie Steel
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Address
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Dr Amie Steel – Associate Director Research
Endeavour College of Natural health.
Level 2/269 Wickham St,
Fortitude Valley QLD 4006
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Country
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Australia
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Phone
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+61 07 3253 9523
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Fax
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Email
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[email protected]
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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
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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