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Trial registered on ANZCTR


Registration number
ACTRN12618001655235
Ethics application status
Approved
Date submitted
24/09/2018
Date registered
8/10/2018
Date last updated
30/04/2019
Date data sharing statement initially provided
30/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Pharmacokinetics of broccoli sprout extract in preeclampsia.
Scientific title
Investigating the pharmacokinetic profile of broccoli sprout extract in women with preeclampsia.
Secondary ID [1] 296163 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preeclampsia 309782 0
Condition category
Condition code
Reproductive Health and Childbirth 308573 308573 0 0
Antenatal care
Reproductive Health and Childbirth 308574 308574 0 0
Fetal medicine and complications of pregnancy
Reproductive Health and Childbirth 308575 308575 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nutritional supplement, orally administered.
Dose 1. Six women will each receive a single dose of four (32mg) activated broccoli sprout extract delayed release capsules

Dose 2. Six women will each receive a single dose of six (48mg) activated broccoli sprout extract delayed release capsules

Dose 3. Six women will each receive a single dose of eight (64mg) activated broccoli sprout extract delayed release capsules

Four, six or eight delayed release, broccoli sprout capsules (Broccomax®) (each containing 8 mg of activated sulforaphane) once.

The administration of the trial intervention will be a once off dose.
Intervention code [1] 312490 0
Treatment: Other
Comparator / control treatment
No control group (dose escalation pharmacokinetic study)

Dose comparison.
Control group
Dose comparison

Outcomes
Primary outcome [1] 307534 0
Blood samples will be taken at a number of time points and will be centrifuged to separate haematocrit form serum. Serum will be collected and stored at -80 until analysis. Circulating levels of sulforaphane metabolites in serum will be quantitatively determined at each time point using liquid-chromatography mass-spectrometry.
Timepoint [1] 307534 0
Blood samples will be collected at baseline and a number of time points after ingestion of the intervention, as described below.

Baseline, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours.

As we are establishing a pharmacokinetic profile of sulforaphane metabolites each time point will be assessed as a primary time point. The baseline time point will act as a control.
Secondary outcome [1] 352248 0
Maternal blood pressure will be assessed at baseline and a number of time points after ingestion of the intervention. Blood pressure will be measured by automated cuff dedicated to the project with the same cuff used for every participants. Blood pressure will be recorded in a red cap database on password protected devices. Blood pressure at each time point will be compared to control (baseline).
Timepoint [1] 352248 0
Maternal blood pressure will be assessed at baseline and a number of time points after ingestion of the intervention. Maternal blood pressure will be recorded in a red cap database on password protected devices. Maternal blood pressure at each time point will be compared to control (baseline). In addition, blood pressure will be monitored half hourly for the first two hours, hourly for the following two hours and two hourly for the final four hours.

Baseline, 30 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours
Secondary outcome [2] 352499 0
Fetal cardiotocography (CTG) will be assessed at a number of time points. CTG is a measure of fetal heart rate and a means to monitor fetal wellbeing. CTG will be monitored to ensure fetal safety.
Timepoint [2] 352499 0
Continuous CTG monitoring will be done for the first hour. In the absence of any abnormalities, as determined by the treating physician, CTG monitoring will be ceased. If maternal blood pressure falls by more than 30mmHg systolic and/or 15mmHg diastolic from baseline, CTG monitoring will be restarted.

Eligibility
Key inclusion criteria
• • Singleton pregnancy
• Diagnosis of preeclampsia as defined by the according to the SOMANZ guidelines
• Gestation greater than 24+0 weeks.
• Viable fetus, as determined by the treating obstetrician
• Able to safely continue pregnancy for 48 hours, or longer, as determined by the treating obstetrician
• Normal mid-trimester morphology scan, with no detectable significant anomalies.
• Deemed capable of understanding the information provided and able to give written informed consent (with interpreter use as required).
• >18 years of age
• Clinical hypertension in accordance with SOMANZ guidelines
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Eclampsia
• Current use of broccoli sprout extract supplement
• Contraindications to use (eg, intolerance of broccoli)
• Significant uncertainty in ensuring gestational age is within limits
• Unwillingness or inability to follow the procedures outlined in the PI and CF
• Mentally, cognitively or legally incapacitated or ineligible to provide informed consent
• Co-recruitment/participation in another clinical trial where there is a pharmaceutical or herbal or nutritional intervention (such trial interventions would also include: multi-vitamins, minerals, complementary and alternative medicines)
Preexisting inflammatory bowel disease (Ulcerative Colitis and Crohn’s disease)

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Dose escalation study with 3 waves of participants.
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis
Based on the early results from the non-pregnant PK study and the apparent inter-individual variation, we estimate that we require six women per dose group. All continuous measures will be assessed for normality of distribution and compared using non-parametric or parametric testing where appropriate. Continuous data will described using mean (SD) if normally distributed and median (IQR) when the distribution is skewed. Maternal and pregnancy characteristics will be analysed using t-test or Mann-Whitney U, to determine statistical difference between groups and to assess the randomisation.
Biomarker values will be assessed using repeated measure analysis with the baseline value acting as a covariate and post hoc correction used as required. Mean value will be shown over time.
Dichotomous outcomes will be presented as risk ratios with 95% confidence intervals and chi-squared analysis for significance. In the event of a value less than five, Fisher’s Exact will be used to establish a p value, with p<0.05 representing significance.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2018
Actual
26/03/2019
Date of last participant enrolment
Anticipated
1/01/2020
Actual
Date of last data collection
Anticipated
1/01/2020
Actual
Sample size
Target
18
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11988 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 11989 0
Jessie McPherson Private Hospital - Clayton
Recruitment postcode(s) [1] 24136 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 300755 0
Self funded/Unfunded
Name [1] 300755 0
Professor Euan M. Wallace
Country [1] 300755 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
Department of Obstetrics and Gynaecology
Monash Medical Centre, Level 5
246 Clayton Rd, Clayton, Vic, 3168
Country
Australia
Secondary sponsor category [1] 300388 0
None
Name [1] 300388 0
Address [1] 300388 0
Country [1] 300388 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301534 0
Monash Health Human Research Ethics Committee [EC00382]
Ethics committee address [1] 301534 0
Ethics committee country [1] 301534 0
Australia
Date submitted for ethics approval [1] 301534 0
13/08/2018
Approval date [1] 301534 0
10/09/2018
Ethics approval number [1] 301534 0
RES-18-0000-514A

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

Contacts
Principal investigator
Name 87314 0
Prof Euan Wallace
Address 87314 0
Department of Obstetrics and Gynaecology Monash University
Level 5, Monash Medical Centre
246 Clayton Road
Clayton
Victoria 3168
Country 87314 0
Australia
Phone 87314 0
+61395945145
Fax 87314 0
Email 87314 0
euan.wallace@monash.edu
Contact person for public queries
Name 87315 0
Annie Cox
Address 87315 0
Department of Obstetrics and Gynaecology Monash University
Hudson Institute of Medical Research
27-31 Wright St
Clayton
Victoria 3168
Country 87315 0
Australia
Phone 87315 0
+61448375767
Fax 87315 0
Email 87315 0
annie.cox@monash.edu
Contact person for scientific queries
Name 87316 0
Annie Cox
Address 87316 0
Department of Obstetrics and Gynaecology Monash University
Level 5, Monash Medical Centre
246 Clayton Road
Clayton
Victoria 3168
Country 87316 0
Australia
Phone 87316 0
+61448375767
Fax 87316 0
Email 87316 0
annie.cox@monash.edu

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


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.