Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000334808
Ethics application status
Approved
Date submitted
22/03/2012
Date registered
22/03/2012
Date last updated
14/09/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Swinburne Multivitamin Study: The Effects of Multivitamin Supplementation on mood, stress and brain function in older adults
Scientific title
An investigation of multivitamin supplementation on measures of mood, stress and brain function in a healthy cohort of adults aged over 50 years
Secondary ID [1] 280196 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influence of nutrients on mood and stress in healthy older adults 286132 0
Investigate the role of cardiovascular system in relation to mood and stress 286138 0
Condition category
Condition code
Alternative and Complementary Medicine 286322 286322 0 0
Other alternative and complementary medicine
Mental Health 286323 286323 0 0
Studies of normal psychology, cognitive function and behaviour
Cardiovascular 286324 286324 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The current study compares multivitamin supplementation to a placebo. Participants are instructed to take one tablet daily with food, for a period of 16 weeks.

Swisse Women's Ulitivite 50+ V
One tablet per day for 16 weeks.
RETINYL ACETATE (equiv. to 2500 IU of vitamin A) 862.5 mcg
d-ALPHA-TOCOPHERYL ACID SUCCINATE (equiv. vitamin E 24.2 IU) 20 mg
THIAMINE HYDROCHLORIDE (vitamin B1) 30 mg
RIBOFLAVINE (vitamin B2) 30 mg
NICOTINAMIDE (vitamin B3) 20 mg
CALCIUM PANTOTHENATE (vitamin B5) (equiv. pantothenic acid 64.13mg) 70 mg
PYRIDOXINE HYDROCHLORIDE (vitamin B6) (equiv. pyridoxine 24.68mg) 30 mg
CYANOCOBALAMIN (vitamin B12) 115 mcg
CHOLECALCIFEROL (vitamin D3) (equiv. vitamin D 200 IU) 5mcg
BIOTIN (vitamin H) 150 mcg
FOLIC ACID 500 mcg
CALCIUM ASCORBATE DIHYDRATE (vitamin C)(equiv. ascorbic acid 165.3mg) 200 mg
PHYTOMENADIONE (vitamin K1) 60 mcg
CITRUS BIOFLAVONOIDS EXTRACT 20 mg
CALCIUM OROTATE (equiv. calcium 10mg) 100 mg
MAGNESIUM ASPARTATE DIHYDRATE (equiv. magnesium 6.74mg) 100 mg
SELENOMETHIONINE (equiv. selenium 26mcg) 65 mcg
MOLYBDENUM TRIOXIDE (equiv. molybdenum 45mcg) 67.5 mcg
CHROMIUM PICOLINATE (equiv. chromium 50 mcg) 402 mcg
MANGANESE AMINO ACID CHELATE (equiv. manganese 3mg) 30 mg
FERROUS FUMERATE (equiv. iron 5mg) 16.01 mg
COPPER GLUCONATE (equiv. copper 1.2mg) 8.57 mg
POTASSIUM IODIDE (equiv. iodine 149.83mcg) (equiv. potassium 46.18mcg) 196 mcg
ZINC AMINO ACID CHELATE (equiv. zinc 15mg) 75 mg
Lactobacillius rhamnosus 80 million organisms
Lactobacillus acidophilus 80 million organisms
Bifidobacterium longum 35 million organisms
VACCINIUM MACROCARPON FRUIT DRY (patented cranberry PACRAN) 800 mg
SILYBUM MARIANUM DRY FRUIT (St. Mary’s thistle) (equiv. flavanolignans calculated as silybin 17.14mg) 1500 mg
GINKGO BILOBA LEAF DRY (Maidenhair tree) (equiv. Ginkgo flavonglycosides 4.8mg and ginkgolides and bilobalide 1.2mg) 1000 mg
TUNERA DIFFUSA LEAF DRY (Damiana) 500 mg
SCUTELLARIA LATERIFLORA HERB DRY (Skullcap) 50 mg
VITIS VINIFERA DRY SEED (Grape seed) (equiv. procyanidins 7.9mg) 1000 mg
URTICA DIOICA LEAF DRY (Nettle) 100 mg
UBIDECARENONE (Co-enzyme Q10) (from patented Ultrasome CoQ10) 2 mg
CYNARA SCOLYMUS LEAF DRY (Globe artichoke) 50 mg
CIMICIFUGA RACEMOSA ROOT & RHIZOME DRY (Black cohosh) 200 mg
CURCUMA LONGA RHIZOME DRY (Tumeric) 100 mg
WITHANIA SOMNIFERA ROOT DRY (Ashwagandha) 500 mg
CRATAEGUS MONOGYNA FRUIT DRY (Hawthorn) 100 mg
SILICA COLLOIDAL ANHYDROUS (equiv. silicon 9.35mg) 20 mg
BACOPA MONNIERI WHOLE PLANT DRY (Bacopa) (equiv. bacosides calculated as bacoside A 1.125mg) 50 mg
LECITHIN POWDER – SOY PHOSPHATIDYLSERINE ENRICHED SOY (equiv. phosphatidylserine 2mg) 10 mg
SPEARMINT OIL 2 mg
VACCINIUM MYRTILLUS FRUIT DRY (Bilberry) (equiv. anthocyanosides 324mcg) 100 mg
TAGETES ERECTA FLOWER DRY (Marigold) (Lutein esters calculated as lutein (of Tagetes erecta) 1mg) 100 mg

Swisse Men's Ultivite 50+ V
Multivitamin, mineral and herbal supplementation.
One tablet per day for 16 weeks.
Swisse Men's Ultivite 50+ V

RETINYL ACETATE (equiv. to 2500 IU of vitamin A) 862.5 mcg
d-ALPHA-TOCOPHERYL ACID SUCCINATE (equiv. vitamin E 30.25 IU) 25 mg
THIAMINE HYDROCHLORIDE (vitamin B1) 35 mg
RIBOFLAVINE (vitamin B2) 35 mg
NICOTINAMIDE (vitamin B3) 25 mg
CALCIUM PANTOTHENATE (vitamin B5) (equiv. pantothenic acid 68.7mg) 75 mg
PYRIDOXINE HYDROCHLORIDE (vitamin B6) (equiv. pyridoxine 20.56mg) 25 mg
CYANOCOBALAMIN (vitamin B12) 120 mcg
CHOLECALCIFEROL (vitamin D3) (equiv. vitamin D 200 IU) 5mcg
BIOTIN (vitamin H) 200 mcg
FOLIC ACID 500 mcg
CALCIUM ASCORBATE DIHYDRATE (vitamin C) (equiv. ascorbic acid 165.3mg) 200 mg
PHYTOMENADIONE (vitamin K) 70 mcg
CITRUS BIOFLAVONOIDS EXTRACT 20 mg
CALCIUM OROTATE (equiv. calcium 10mg) 100 mg
MAGNESIUM ASPARTATE DIHYDRATE (equiv. magnesium 6.74mg) 100 mg
SELENOMETHIONINE (equiv. selenium 26mcg) 65 mcg
MOLYBDENUM TRIOXIDE (equiv. molybdenum 45mcg) 67.5 mcg
CHROMIUM PICOLINATE (equiv. chromium 50 mcg) 402 mcg
MANGANESE AMINO ACID CHELATE (equiv. manganese 4mg) 40 mg
FERROUS FUMERATE (equiv. iron 5mg) 16.01 mg
COPPER GLUCONATE (equiv. copper 1.7mg) 12.14 mg
POTASSIUM IODIDE (equiv. iodine 149.83mcg) (equiv. potassium 46.18mcg) 196 mcg
ZINC AMINO ACID CHELATE (equiv. zinc 20mg) 100 mg
Lactobacillius rhamnosus 80 million organisms
Lactobacillus acidophilus 80 million organisms
Bifidobacterium longum 35 million organisms
VACCINIUM MACROCARPON FRUIT DRY (patented cranberry PACRAN) 1000 mg
SILYBUM MARIANUM DRY FRUIT (St. Mary’s thistle) (equiv. flavanolignans calculated as silybin 19.43mg) 1700 mg
GINKGO BILOBA LEAF DRY (Maidenhair tree) (equiv. Ginkgo flavonglycosides 4.8mg and ginkgolides and bilobalide 1.2mg) 1000 mg
TRIBULUS TERRESTRIS FRUIT & ROOT DRY (Tribulus) 1000 mg
DULACIA INOPIFLORA ROOT DRY (Muirapuama) 200 mg
SCUTELLARIA LATERIFLORA HERB DRY (Skullcap) 50 mg
VITIS VINIFERA DRY SEED (Grape seed) (equiv. procyanidins 7.9mg) 1000 mg
SERENOA REPENS FRUIT DRY (Saw palmetto) (equiv. fatty acids 27mg) 300 mg
URTICA DIOICA LEAF DRY (Nettle) 50 mg
UBIDECARENONE (Co-enzyme Q10) (from patented Ultrasome CoQ10) 3 mg
CYNARA SCOLYMUS LEAF DRY (Globe artichoke) 50 mg
CRATAEGUS MONOGYNA FRUIT DRY (Hawthorn) 120 mg
LECITHIN POWDER – SOY PHOSPHATIDYLSERINE ENRICHED SOY (equiv. phosphatidylserine 2mg) 10 mg
SPEARMINT OIL 2 mg
VACCINIUM MYRTILLUS FRUIT DRY (Bilberry) (equiv. anthocyanosides 324mcg) 100 mg
TAGETES ERECTA FLOWER DRY (Marigold) (Lutein esters calculated as lutein (of Tagetes erecta) 1mg) 100 mg
Intervention code [1] 284521 0
Other interventions
Comparator / control treatment
Placebo:One tablet per day for 16 weeks. Women's:One tablet per day for 16 weeks. EXCIPIENTS: CELLULOSE-MICROCRYSTALLINE CROSPOVIDONE CROSCARMELLOSE SODIUM POVIDONE MAGNESIUM STEARATE COATING: HYPROMELLOSE CACROGOL 400 TITANIUM DIOXIDE IRON OXIDE RED IRON OXIDE YELLOW SPEARMINT OIL CARNAUBA WAX Men's:One tablet per day for 16 weeks. EXCIPIENTS: CELLULOSE-MICROCRYSTALLINE CROSPOVIDONE CROSCARMELLOSE SODIUM POVIDONE SILICON DIOXIDE MAGNESIUM STEARATE COATING: CHLOROPHYLLIN COPPER COMPLEX OPADRY II WHITE SPEARMINT OIL CARNAUBA WAX
Control group
Placebo

Outcomes
Primary outcome [1] 286793 0
Scores on mood and stress scales. These scales include:
-Beck Depression Inventory (BDI)
-Beck Anxiety Inventory (BAI)
-The Depression, Anxiety, Stress Scale (DASS)
-The Perceived Stress Scale (PSS)
-The Hospital Depression and Anxiety Scale (HADS)
Timepoint [1] 286793 0
Before and after 16 weeks of supplementation
Primary outcome [2] 286794 0
patterns of brain electrical activity using the steady state visual evoked potential technique
Timepoint [2] 286794 0
Before and after 16 weeks of supplementation
Primary outcome [3] 286795 0
Stress/mood using multitasking battery to induce stress and mood questionnaires before and after stress task. The questionnaires include
-Bond Lader Visual Analogue Scales
-The State/Trait anxiety Index (STAI)
-The NASA-task load index (After task only)
Timepoint [3] 286795 0
Before and after 16 weeks of supplementation
Secondary outcome [1] 296667 0
Blood levels of: homocysteine; c-reactive protein; fibrinogen; lipids; vitamins B6, B12, E, zinc and folate; electrolytes; telomere length.
Timepoint [1] 296667 0
Before and after 16 weeks of supplementation
Secondary outcome [2] 296668 0
Cardiovascular function using transcranial doppler ultrasound and arterial stiffness measure (using sphygmocor system)
Timepoint [2] 296668 0
Before and after 16 weeks of supplementation

Eligibility
Key inclusion criteria
-Right-handed
-free from psychiatric disorders
-Must not be taking anticoagulants, antidepressants, antipsychotics, anxiolytics, acetylcholine esterase (AChE) inhibitors, anti-Parkinson’s medication, illicit drugs or any cognitive enhancing drugs
-must not be taking any vitamin/mineral or herbal supplements
-non-smoker
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
-smokers
-psychiatric disorders
-using vitamins/minerals or herbal supplements
-taking anticoagulants, antidepressants, antipsychotics, anxiolytics, acetylcholine esterase (AChE) inhibitors, anti-Parkinson’s medication, illicit drugs or any cognitive enhancing drugs
-left-handed

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 through our internal clinical trials database. Participants are randomly assigned to numbered containers which the sponsor randomly allocated to one of the treatment conditions. The individual who screened participants and conducted testing was not involved or aware of the allocation of supplements.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
None
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/09/2009
Actual
12/05/2011
Date of last participant enrolment
Anticipated
Actual
25/06/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
84
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 284944 0
Commercial sector/Industry
Name [1] 284944 0
Swisse Vitamins Pty Ltd
Country [1] 284944 0
Australia
Primary sponsor type
University
Name
Swinburne University
Address
Street and Postal Address:
Centre for Human Psychopharmacology,
Swinburne Univeristy of Technology,
427-457 Burwood Road,
Hawthorn, VIC, 3122
Country
Australia
Secondary sponsor category [1] 283818 0
None
Name [1] 283818 0
Address [1] 283818 0
Country [1] 283818 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286955 0
Swinburne University Human Research Ethics Committee (SUHREC)
Ethics committee address [1] 286955 0
Ethics committee country [1] 286955 0
Australia
Date submitted for ethics approval [1] 286955 0
Approval date [1] 286955 0
08/04/2009
Ethics approval number [1] 286955 0
SUHREC Project 2008/147 The effect of multivitamin supplementation on mood, stress and brain electrical activity

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

Contacts
Principal investigator
Name 33963 0
A/Prof Andrew Pipingas
Address 33963 0
Centre for Human Psychopharmacology Swinburne Univeristy of Technology, 427-457 Burwood Road, Hawthorn, VIC, 3122, Australia
Country 33963 0
Australia
Phone 33963 0
+61 3 9214 5215
Fax 33963 0
Email 33963 0
[email protected]
Contact person for public queries
Name 17210 0
Renee Rowsell
Address 17210 0
Centre for Human Psychopharmacology
Swinburne Univeristy of Technology,
427-457 Burwood Road,
Hawthorn, VIC, 3122, Australia.
Country 17210 0
Australia
Phone 17210 0
+61 3 9214 5656
Fax 17210 0
Email 17210 0
[email protected]
Contact person for scientific queries
Name 8138 0
Dr. Andrew Pipingas
Address 8138 0
Centre for Human Psychopharmacology
Swinburne Univeristy of Technology,
427-457 Burwood Road,
Hawthorn, VIC, 3122, Australia.
Country 8138 0
Australia
Phone 8138 0
+61 3 9214 5215
Fax 8138 0
Email 8138 0
[email protected]

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