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Trial registered on ANZCTR


Registration number
ACTRN12616000086460
Ethics application status
Approved
Date submitted
21/01/2016
Date registered
27/01/2016
Date last updated
22/12/2020
Date data sharing statement initially provided
22/12/2020
Date results provided
22/12/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of dietary nitrate supplementation on brain blood vessel health
Scientific title
Effect of dietary nitrate supplementation on cerebrovascular health in high risk transient ischaemic attack (TIA) patients
Secondary ID [1] 288381 0
Nil known
Universal Trial Number (UTN)
U1111-1163-5318
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Transient ischaemic attack 297386 0
Condition category
Condition code
Stroke 297575 297575 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
7 day dietary sodium nitrate supplementation, 0.1mmol/kg/day (rounded to the nearest 60mg), administered in oral capsules (sodium nitrate, 60mg/capsule) across the meals (3 times daily). Adherence will be monitored by self-report, empty drug packet and assessment of pre and post blood plasma nitrate concentration.
Intervention code [1] 293687 0
Treatment: Other
Comparator / control treatment
TIA patients with 7 day placebo treatment containing sugar
healthy subjects with 7 day dietary nitrate supplementation and 7 day placebo treatment with a minimum 5 day washout period.
Control group
Placebo

Outcomes
Primary outcome [1] 297122 0
Cerebral blood flow regulation using transcranial Doppler ultrasound.
Timepoint [1] 297122 0
Post 7 days of treatment
Primary outcome [2] 297132 0
cerebral tissue oxygenation using Near-infrared spectroscopy
Timepoint [2] 297132 0
Post 7 days of treatment
Secondary outcome [1] 320083 0
blood pressure control using finger plethysmography.
Timepoint [1] 320083 0
Post 7 days of treatment
Secondary outcome [2] 320118 0
Peripheral arterial stiffness using flow-mediated dilatation. Assessing using Duplex Doppler ultrasound.
Timepoint [2] 320118 0
post 7 days of treatment

Eligibility
Key inclusion criteria
Patient group
1) Those individuals aged 40-85 diagnosed as high risk TIA (with ABCD2 score greater than or equal to 4), after review by a specialist stroke physician
2) Those individuals living within Wellington City and the Greater Wellington region
Healthy group
1) Healthy individuals (age 20-85 years) of both sex, specifically:
2) Free of history of long-term disease
3) Not currently taking any medication that may influence measures in this study.
4) Those individuals living within Wellington City and the Greater Wellington region
Minimum age
20 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patient group
1) Those individuals requiring supplementary oxygen
2) Individuals with allergy to nitrates
3) Unstable cardiac conditions or angina
4) Uncontrolled diabetes mellitus
5) Major medical conditions
6) Significant cognitive impairment
7) Immobility

Healthy group
1) Very high (greater than 140/90) or very low (lower than 100/60) resting blood pressure
2) Previous history of stroke, brain surgery, or severe head trauma
3) Pregnancy

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Other
Other design features
The TIA patient group will undergo a parallel design, whilst the healthy control group will be crossover design
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
One of the primary dependent variables of interest is cerebral blood flow regulation. The sample size estimate was based on published (Aamand et al 2013; 2014; Presley et al 2011) and unpublished pilot data, which has assessed the effects of dietary nitrate on cerebrovascular function. These were used to estimate a physiologically relevant improvement in cerebrovascular function of 16% between the two randomized groups. Assuming that dietary nitrate supplementation can improve cerebrovascular function by a similar extent, 17 TIA patients per group (34 TIA patients total) and 17 healthy controls would provide > 80% power to detect a moderate effect size that corresponds to a ~100% difference between treatment and placebo interventions, assuming a standard deviation of 0.65%/mmHg at a two-tailed significance level of 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/09/2015
Date of last participant enrolment
Anticipated
31/08/2018
Actual
31/05/2018
Date of last data collection
Anticipated
Actual
7/06/2018
Sample size
Target
36
Accrual to date
Final
36
Recruitment outside Australia
Country [1] 7544 0
New Zealand
State/province [1] 7544 0
Wellington region

Funding & Sponsors
Funding source category [1] 292739 0
Charities/Societies/Foundations
Name [1] 292739 0
New Zealand Heart Foundation
Country [1] 292739 0
New Zealand
Primary sponsor type
Individual
Name
Mickey Fan
Address
University of Otago
23A Mein Street
Newtown
Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 291466 0
University
Name [1] 291466 0
University of Otago
Address [1] 291466 0
362 Leith St, North Dunedin, Dunedin 9016
Country [1] 291466 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294223 0
Health and Disability Ethics Committees
Ethics committee address [1] 294223 0
Ethics committee country [1] 294223 0
New Zealand
Date submitted for ethics approval [1] 294223 0
05/02/2015
Approval date [1] 294223 0
30/03/2015
Ethics approval number [1] 294223 0
15/CEN/10

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

Contacts
Principal investigator
Name 62942 0
Dr Mickey Fan
Address 62942 0
University of Otago
23A Mein Street
Newtown
Wellington 6021
Country 62942 0
New Zealand
Phone 62942 0
+64 4 918 5395
Fax 62942 0
Email 62942 0
[email protected]
Contact person for public queries
Name 62943 0
Mickey Fan
Address 62943 0
Mickey Fan
University of Otago
23A Mein Street
Newtown
Wellington 6021
Country 62943 0
New Zealand
Phone 62943 0
+64 4 918 5395
Fax 62943 0
Email 62943 0
[email protected]
Contact person for scientific queries
Name 62944 0
Mickey Fan
Address 62944 0
Mickey Fan
University of Otago
23A Mein Street
Newtown
Wellington 6021
Country 62944 0
New Zealand
Phone 62944 0
+64 4 918 5395
Fax 62944 0
Email 62944 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.