Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000256370
Ethics application status
Approved
Date submitted
20/05/2008
Date registered
20/05/2008
Date last updated
3/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of multivitamin supplementation on memory and brain function in elderly women experiencing memory decline.
Scientific title
A 16 week, double blind, placebo controlled investigation of the effects of Swisse Ultivite 50+ Women's formula on memory, cognition and brain function in women aged 65 years and over with memory decline.
Secondary ID [1] 253492 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Memory decline 3148 0
Cognitive and memory performance 3149 0
Brain function 3150 0
Cardiovascular function 3151 0
Blood markers of antioxidant status and general health 3152 0
Condition category
Condition code
Mental Health 3307 3307 0 0
Studies of normal psychology, cognitive function and behaviour
Neurological 3308 3308 0 0
Dementias
Cardiovascular 3309 3309 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 2885 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
Control group
Placebo

Outcomes
Primary outcome [1] 4200 0
Patterns of brain activity during memory activation tasks using the steady state visually evoked potential (SSVEP) methodology.
Timepoint [1] 4200 0
Baseline and following 16 weeks supplementation.
Primary outcome [2] 4201 0
Performance on a computerised cognitive task battery. memory performance on standard neuropsychological tasks.
Timepoint [2] 4201 0
Baseline and following 16 weeks supplementation.
Secondary outcome [1] 7099 0
Blood pressure and augmentation index as measured by the Sphygmocor pulse wave analysis system
Timepoint [1] 7099 0
Baseline and following 16 weeks supplementation.
Secondary outcome [2] 7100 0
Levels of homocysteine; c-reactive protein; fibrinogen; lipids; vitamins B6, B12, C, E and folate; and protein carbonyls in the blood.
Timepoint [2] 7100 0
Baseline and following 16 weeks supplementation.

Eligibility
Key inclusion criteria
Females aged 65- 80 years who are experiencing memory decline.
Minimum age
65 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Smoking; current supplementation with multivitamins; history of psychiatric disorder, neurological disease, dementia.

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)
Placebo and treatment were randomised by Swisse Vitamins Pty Ltd and packaged in identical blister packs. Packets were numbered according to the randomization schedule, which is held by Swisse Vitamins. Participants are allocated the next sequential number upon enrolement to the study.
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
A control group who are free from memory impairment will not participate in the clinical trial, but will provide baseline cognitive, brain function and cardiovascular data.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/05/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3403 0
Commercial sector/Industry
Name [1] 3403 0
Swisse Vitamins Pty Ltd
Country [1] 3403 0
Australia
Primary sponsor type
Individual
Name
Dr Andrew Pipingas
Address
Brain Sciences Institute 400 Burwood Rd Hawthorn Victoria 3121
Country
Australia
Secondary sponsor category [1] 3047 0
Individual
Name [1] 3047 0
Helen Macpherson
Address [1] 3047 0
Brain Sciences Institute 400 Burwood Rd Hawthorn Victoria 3121
Country [1] 3047 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5432 0
Swinburne University Human Research Ethics Committee
Ethics committee address [1] 5432 0
Swinburne University Hawthorn Victoria 3121
Ethics committee country [1] 5432 0
Australia
Date submitted for ethics approval [1] 5432 0
Approval date [1] 5432 0
19/02/2008
Ethics approval number [1] 5432 0
0708/063

Summary
Brief summary
This study is a 16 week, double blind, placebo controlled investigation of the effects of a Women’s 50+ multivitamin antioxidant supplement on memory and brain function in women aged 65 to 80 years who are experiencing memory decline. Additionally, this study aims to investigate the possible mechanisms which underlie memory impairment in older adults including cardiovascular risk factors, oxidative stress and brain activity (EEG).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28589 0
Address 28589 0
Country 28589 0
Phone 28589 0
Fax 28589 0
Email 28589 0
Contact person for public queries
Name 11746 0
Helen Macpherson
Address 11746 0
Brain Sciences Institute
400 Burwood Rd Hawthorn 3121
Country 11746 0
Australia
Phone 11746 0
03 9214 5585
Fax 11746 0
Email 11746 0
[email protected]
Contact person for scientific queries
Name 2674 0
Helen Macpherson
Address 2674 0
Brain Sciences Institute
400 Burwood Rd Hawthorn 3121
Country 2674 0
Australia
Phone 2674 0
03 9214 5585
Fax 2674 0
Email 2674 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
No additional documents have been identified.