Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000874617
Ethics application status
Approved
Date submitted
22/07/2014
Date registered
14/08/2014
Date last updated
21/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effects of a high DHA fish oil supplement on cognitive performance in older adults with Mild Cognitive Impairment: A 12-month randomised, double-blind, placebo controlled trial based in Wellington, New Zealand
Scientific title
In older adults with mild cognitive impairment, do omega-3 fatty acids compared to a placebo improve cognitive performance?
Secondary ID [1] 284693 0
Nil
Universal Trial Number (UTN)
U1111-1157-4846
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Cognitive Impairment 292047 0
Condition category
Condition code
Neurological 292383 292383 0 0
Dementias
Mental Health 292917 292917 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12 month intervention of 1500 mg of docosahexaenoic acid (DHA) and 300 mg of eicosapentaenoic acid (EPA) per day. Participants will take 3 x 500mg of DHA+100mg of EPA capsules in the morning with breakfast every day for 12 months. Participants will be given 4 bottles of capsules (each containing 200 capsules) at the end of the baseline testing session, another bottle at the end of the 2nd session and the final bottle at the end of the 3rd testing session. Participants will be required to return the capsule bottles with all unused capsules to the following testing sessions.
Intervention code [1] 289557 0
Treatment: Drugs
Intervention code [2] 289870 0
Behaviour
Comparator / control treatment
Sunflower oil. Participants will take 3 capsules in the morning with breakfast for 12 months.
Control group
Placebo

Outcomes
Primary outcome [1] 292725 0
Rate of cognitive improvement or decline using the following battery of tests:: Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), the Californina Older Adult Stroop Test (COAST), the Coin Rotation Task (CRT), the Trail Making Test A and B (TMT), the National Adult Reading Test (NART) and the Digit Span backwards test (DSBT) from the Weschler Adult Intelligence Scale 3 (WAIS-III).
Timepoint [1] 292725 0
Participants will be tested on the cognitive tests at baseline, after 6 and 9 months of taking the supplements and lastly a final testing session after 12-months at end of the trial.
Primary outcome [2] 292781 0
Change in well-being measures: Geriatric Depression Scale (GDS) SF-36 Short Form 36 and the Geriatric Anxiety Inventory (GAI).
Timepoint [2] 292781 0
Participants will be tested on the cognitive tests at baseline, after 6 and 9 months of taking the supplements and lastly a final testing session after 12-months at end of the trial.
Secondary outcome [1] 309556 0
Changes in weight. Tested using a digital scale.
Timepoint [1] 309556 0
Baseline testing session and at the final testing session after 12-months at the end of the trial.
Secondary outcome [2] 309562 0
Blood pressure. Tested using a digital sphygmomanometer.
Timepoint [2] 309562 0
Baseline testing session and at the final testing session after 12-months at the end of the trial.
Secondary outcome [3] 309686 0
Presence or absence of APOE 4 gene by way of a blood sample using polymerase chain reaction analysis.
Timepoint [3] 309686 0
At the final testing session after 12-months at the end of the trial.

Eligibility
Key inclusion criteria
Inclusion criteria for participants will be a diagnosis of cognitive impairment based on neuropsychological assessment and self-reporting. Agree to not start taking own fish oil supplement during the 12-month trial.
.
Minimum age
60 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Major medical conditions including head injury or recent major surgery, problem swallowing capsules, consumption of 3 more more servings of oily fish per week, consumption of fish oil supplements in the last 12 months and an allergy to fish or seafood.

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)
Allocation concealed when it was done by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation using computer software.
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
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
4 repeat testing sessions at baseline, after 6 months and 9 months of taking the supplements and lastly a final testing session after 12-months at end of the trial

This study will require a minimum of 50 older adults with Mild Cognitive Impairment, 25 participants in each capsule group. This sample-size calculation was based on a small effect size of 0.25, also a difference in z score of 0.5 and to prove a statistical power equal to 0.99 at a a level of 0.05 (2 tailed). Allowing for an attrition rate of 16% based on previous studies, an initial sample of 65 participants will be required to give sufficient power to detect the primary effects.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2014
Actual
1/12/2015
Date of last participant enrolment
Anticipated
Actual
31/05/2016
Date of last data collection
Anticipated
31/07/2017
Actual
31/07/2017
Sample size
Target
65
Accrual to date
Final
72
Recruitment outside Australia
Country [1] 6241 0
New Zealand
State/province [1] 6241 0
Wellington

Funding & Sponsors
Funding source category [1] 289644 0
University
Name [1] 289644 0
Massey University Wellington
Country [1] 289644 0
New Zealand
Funding source category [2] 292304 0
Charities/Societies/Foundations
Name [2] 292304 0
The Neurological Foundation
Country [2] 292304 0
New Zealand
Funding source category [3] 292305 0
Charities/Societies/Foundations
Name [3] 292305 0
Oakley Mental Health Foundation
Country [3] 292305 0
New Zealand
Funding source category [4] 292306 0
Charities/Societies/Foundations
Name [4] 292306 0
Hope-Selwyn Foundation Scholarship in Ageing Research
Country [4] 292306 0
New Zealand
Primary sponsor type
Individual
Name
Alexia Mengelberg
Address
Massey University
Wallace Street
Mt Cook
Wellington 6021
New Zealand
Country
New Zealand
Secondary sponsor category [1] 288335 0
None
Name [1] 288335 0
Address [1] 288335 0
Country [1] 288335 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291385 0
Health and Disability Ethics Committee
Ethics committee address [1] 291385 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6011
Ethics committee country [1] 291385 0
New Zealand
Date submitted for ethics approval [1] 291385 0
14/08/2014
Approval date [1] 291385 0
28/10/2014
Ethics approval number [1] 291385 0

Summary
Brief summary
Study design: 12-month randomised, double-blind, placebo-controlled intervention trial with 4 measurement points.
Participants: 72 men & women, aged 60-90 years with Mild Cognitive Impairment.
Intervention: Half the participants will receive fish-oil capsules and the other half will receive placebo capsules for 12 months.

Outcome measures: cognitive performance, well-being, blood pressure and weight.
Demographic and nutritional data will be collected as covariates.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48814 0
Miss Alexia Mengelberg
Address 48814 0
Massey University Wellington
PO Box 756
Wellington 6140
New Zealand
Country 48814 0
New Zealand
Phone 48814 0
+64 04 801 5799 ext. 63844
Fax 48814 0
Email 48814 0
[email protected]
Contact person for public queries
Name 48815 0
Miss Alexia Mengelberg
Address 48815 0
Massey University Wellington
PO Box 756
Wellington 6140
New Zealand
Country 48815 0
New Zealand
Phone 48815 0
+64 04 801 5799 ext. 63883
Fax 48815 0
Email 48815 0
[email protected]
Contact person for scientific queries
Name 48816 0
Miss Alexia Mengelberg
Address 48816 0
Massey University Wellington
PO Box 756
Wellington 6140
New Zealand
Country 48816 0
New Zealand
Phone 48816 0
+64 04 801 5799 ext. 63844
Fax 48816 0
Email 48816 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
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Documents added automatically
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