Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001087741
Ethics application status
Approved
Date submitted
26/09/2013
Date registered
27/09/2013
Date last updated
15/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Understanding the behavioural effects of multivitamin supplements
Scientific title
Understanding the behavioural effects of multivitamin supplements: The BEMS study in women
Secondary ID [1] 283312 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The influence of multivitamins on mood and cognition 290195 0
The behavioural effects of multivitamins 290196 0
Condition category
Condition code
Alternative and Complementary Medicine 290585 290585 0 0
Other alternative and complementary medicine
Mental Health 290586 290586 0 0
Studies of normal psychology, cognitive function and behaviour
Cardiovascular 290587 290587 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this study participants will supplement their diet with one multivitamin, (or placebo) supplement each day for
30 days. The investigational product will be the Swisse Women’s 50+ Ultivite. The multivitamin is available
over the counter in Australian supermarkets and chemists.
Participants will be given a tablet log to mark off each day, once they have taken their supplement. All remaining tablets, along with the log, will be returned at the end of the supplementation period to monitor compliance.

EACH MULTIVITAMIN TABLET CONTAINS:
Vitamin A 2500 IU (retinyl acetate 750 mcg RE)Vitamin E 24.2 IU (d-alpha tocopheryl acid succinate 20 mg)
Vitamin D3 200 IU (cholecalciferol 5 mcg)
Vitamin B1 (thiamine hydrochloride 30 mg)
Vitamin B2 (riboflavin 30 mg)
Nicotinamide 20 mg
Vitamin B5 (pantothenic acid 64.13 mg from calcium pantothenate 70 mg)
Vitamin B6 (pyridoxine 24.68 mg from pyridoxine hydrochloride 30 mg)
Vitamin B12 (cyanocobalamin 115 mcg)
Biotin 150 mcg
Folic acid 500 mcg
Vitamin K (phytomenadione 60 mcg)
Vitamin C (ascorbic acid 165.3 mg from calcium ascorbate dihydrate 200 mg)
Citrus bioflavonoids extract 20 mg
Calcium 10 mg (calcium orotate 100 mg)
Magnesium 7.5 mg (magnesium aspartate dihydrate 100 mg)
Selenium 26 mcg (selenomethionine 65 mcg)
Molybdenum 45 mcg (molybdenum trioxide 67.5 mcg)
Chromium 50 mcg (chromium picolinate 402mcg)
Manganese 3 mg (manganese amino acid chelate 30 mg)
Iron 5 mg (ferrous fumarate 16.01 mg)
Copper 1.2 mg (copper gluconate 8.57 mg)
Zinc 15 mg (zinc amino acid chelate 75 mg)
Iodine 149.83 mcg (potassium iodide 196 mcg)
Silicon 9.35 mg (silica colloidal anhydrous 20 mg)
Lecithin powder – soy phosphatidylserine enriched soy 10 mg (phosphatidylserine 2 mg)
Co-enzyme Q10 (ubidecarenone 2 mg)
Spearmint oil 2 mg
Lutein 1 mg
EXTRACTS EQUIVALENT TO DRY:
Skullcap 50 mg (Scutellaria lateriflora herb)
Nettle 100 mg (Urtica dioica leaf)
Black cohosh 200 mg (Cimicifuga racemosa root & rhizome)
Withania 500 mg (Withania somnifera root)
Damiana 500 mg (Turnera diffusa leaf)
Hawthorn 100 mg (Crataegus monogyna fruit)
EXTRACTS EQUIVALENT TO FRESH:
Cranberry 800 mg (Vaccinium macrocarpon fruit)
Globe artichoke 50 mg (Cynara scolymus leaf)
STANDARDISED EXTRACTS EQUIVALENT TO:
Brahmi 50 mg (Bacopa monnieri whole plant dry)
Grape seed 1.0 g (Vitis vinifera seed dry)
Ginkgo 1.0 g (Ginkgo biloba leaf dry)
St. Mary’s thistle 1.5 g (Silybum marianum fruit dry)
Turmeric 100 mg (Curcuma longa rhizome dry)
Bilberry 100 mg (Vaccinium myrtillus fruit fresh)
Intervention code [1] 288030 0
Other interventions
Comparator / control treatment
Placebo.
Participants allocated to the placebo group will be required to supplement their diet with one tablet each day for 30 days.
Control group
Placebo

Outcomes
Primary outcome [1] 290600 0
Change in ratings of energy levels, alertness, stress and anxiety, as measured by the visual analogue scales.
Timepoint [1] 290600 0
Before and after 30 days of supplementation
Primary outcome [2] 290612 0
Change in scores on the GHQ
Timepoint [2] 290612 0
Before and after 30 days of supplementation
Secondary outcome [1] 304877 0
Acute effects (assessed 1 hour post treatment):
Acute cognitive effects of the multivitamin will be assessed at 1 hour post-treatment, using the SUCCAB and mobile phone paired associates, little man and serial sevens tests.
Timepoint [1] 304877 0
At baseline, and one-hour post dose (day 1).
Secondary outcome [2] 304878 0
Acute effects:
acute mood effects will be assessed at 1 hour post-treatment using the STAI – state, DASS and mobile phone VAS mood measures.
Timepoint [2] 304878 0
At baseline, and one-hour post dose (day 1).
Secondary outcome [3] 304903 0
Chronic effects (assessed 1 month post treatment):
Chronic cognitive effects of the multivitamin will be assessed at 1 month post-treatment using the SUCCAB and mobile phone paired associates, little man and serial sevens tests.
Timepoint [3] 304903 0
Before and after 30 days of supplementation
Secondary outcome [4] 304904 0
Chronic mood effects will be assessed using the DASS, HADS, PSS, STAI, Chalder Fatigue scale, and mobile phone VAS mood measures.
Timepoint [4] 304904 0
Before and after 30 days of supplementation
Secondary outcome [5] 304905 0
Cardiovascular health will be assessed using the Sphygmocor system.
Timepoint [5] 304905 0
Before and after 30 days of supplementation

Eligibility
Key inclusion criteria
1. Female
2. Aged 50 - 75 years
3. Not currently working fulltime
4. Non-smokers
5. English speaking
6. Free from other medical conditions which may affect ability to participate in the study.
Minimum age
50 Years
Maximum age
75 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Smoker
2. History of diabetes or cardiovascular disease
3. History of epilepsy or Parkinson’s disease.
4. History of anxiety, depression, or psychiatric disorders.
5. History of dementia, stroke and other neurological conditions, head trauma.
6. MMSE score less than 25/30
7. Alcohol abuse past/present.
8. Use of, vitamin E, multivitamins, B vitamin complex, ginkgo biloba, fish oil, St John’s Wort or other cognitive enhancing dietary or herbal supplement in the 4 weeks preceding the baseline study visit.
9. Not willing to abstain from using vitamin E, multivitamins, B vitamin complex, ginkgo biloba, fish oil, St John’s Wort, or other cognitive enhancing dietary or herbal supplements over the study period.
10. Taking the following: high dose anti-coagulant drugs (Warfarin, Heparin, Plavix); anti-cholinergics or acetylcholinesterase inhibitors: bethanechol (Ureholine), donepezil (Aricept), rivastigmine (Exelon), galantamine (Reminyl), edrophonium (Enoln, Reversol, Tensilon), neostigmine (Prostigmin).
11. Use of anti-depressant medications such as Sertraline (Zoloft), paroxetine (Paxil), fluoxetine (Prozac) or any other antidepressant medication.
12. Taking anti-anxiety medication such as diazepam (Valium), alprazolam (Xanax).

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)
Participants will be recruited via newspaper advertisements as well as our internal clinical trials database. Participants will be randomly assigned to numbered containers which will have been randomly allocated to one of the treatment conditions by an individual not involved in the project.
The individuals involved int the recruitment, screening and testing of participants will not be involved in or aware of the treatment allocations.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
A power analysis was conducted in order to detrmine the sample size needed in order to detect an effect size of .29. To have 80% chance of detecting an effect size of this magnitude (F=.15) in a two armed study (multivitamin, placebo) with at least 3 time points (baseline, 1 hour post-treatment, 1 month post treatment) a total sample of 75 participants would be required (alpha level = .05). To account for a 15% drop out rate, 86 participants will be included in the study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/10/2013
Actual
19/11/2013
Date of last participant enrolment
Anticipated
Actual
20/06/2014
Date of last data collection
Anticipated
Actual
16/07/2014
Sample size
Target
86
Accrual to date
Final
76
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 288043 0
Commercial sector/Industry
Name [1] 288043 0
Swisse Vitamins Pty Ltd
Country [1] 288043 0
Australia
Primary sponsor type
University
Name
Swinburne University
Address
Centre for Human Psychopharmacology
Swinburne University of Technology
427-457 Burwood Rd,
Hawthorn VIC, 3122
Country
Australia
Secondary sponsor category [1] 286769 0
None
Name [1] 286769 0
Address [1] 286769 0
Country [1] 286769 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289968 0
Swinburne University Human Research Ethics Committee (SUHREC)
Ethics committee address [1] 289968 0
Ethics committee country [1] 289968 0
Australia
Date submitted for ethics approval [1] 289968 0
Approval date [1] 289968 0
21/08/2013
Ethics approval number [1] 289968 0

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

Contacts
Principal investigator
Name 43314 0
Dr Helen Macpherson
Address 43314 0
Centre for Human Psychopharmacology
Swinburne University of Technology
427-457 Burwood Rd,
Hawthorn VIC 3122
Country 43314 0
Australia
Phone 43314 0
+61 03 92145585
Fax 43314 0
Email 43314 0
[email protected]
Contact person for public queries
Name 43315 0
Helen Macpherson
Address 43315 0
Centre for Human Psychopharmacology
Swinburne University of Technology
427-457 Burwood Rd,
Hawthorn VIC 3122
Country 43315 0
Australia
Phone 43315 0
+61 03 92145585
Fax 43315 0
Email 43315 0
[email protected]
Contact person for scientific queries
Name 43316 0
Helen Macpherson
Address 43316 0
Centre for Human Psychopharmacology
Swinburne University of Technology
427-457 Burwood Rd,
Hawthorn VIC 3122
Country 43316 0
Australia
Phone 43316 0
+61 03 92145585
Fax 43316 0
Email 43316 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAcute mood but not cognitive improvements following administration of a single multivitamin and mineral supplement in healthy women aged 50 and above: a randomised controlled trial.2015https://dx.doi.org/10.1007/s11357-015-9782-0
EmbaseThe Effects of Four-Week Multivitamin Supplementation on Mood in Healthy Older Women: A Randomized Controlled Trial.2016https://dx.doi.org/10.1155/2016/3092828
N.B. These documents automatically identified may not have been verified by the study sponsor.