Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000591651
Ethics application status
Approved
Date submitted
9/05/2023
Date registered
31/05/2023
Date last updated
9/05/2024
Date data sharing statement initially provided
31/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of maternal-fetal transfer of sulforaphane and metabolites
Scientific title
Assessment of maternal-fetal transfer of sulforaphane and metabolites in umbilical cord blood and expressed breast milk
Secondary ID [1] 309630 0
Nil known
Universal Trial Number (UTN)
U1111-1290-8991
Trial acronym
Linked study record
This study is paired with ACTRN12623000592640 as it is investigating the maternal-fetal transfer of broccoli sprout supplements. This study is looking at the placental transfer of broccoli sprout and metabolites where as the other study is looking at the pharmacokinetic curve in pregnant participants.

Health condition
Health condition(s) or problem(s) studied:
Preeclampsia 329959 0
Condition category
Condition code
Reproductive Health and Childbirth 326865 326865 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two capsules of broccoli sprout extract GeneActiv Formulation E by Cell-Logic (1400mg)
Total sulforaphane dose 21mg

Two doses per trial participant

Dose 1 - At least 2 hours prior to planned elective caesarean section
Dose 2 - At least 2 hours prior to planned breast feed on post-natal day 2 or 3

Participants will be observed at the time of capsule consumption for compliance at both time points for the two doses.
Intervention code [1] 326060 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334713 0
Concentration of sulforaphane and metabolites in umbilical cord blood at time of caesarean section
Timepoint [1] 334713 0
At least two hours post dose 1
Secondary outcome [1] 421831 0
Concentration of sulforaphane and metabolites in post-natal expressed breast milk
Timepoint [1] 421831 0
At least 2 hours post dose 2 on post-natal day 2 or 3
Secondary outcome [2] 421832 0
Concentration of sulforaphane and metabolites in peripheral maternal blood sample
Timepoint [2] 421832 0
Pre-dose (baseline) At time of caesarean section (at least 2-hours post dose) Post-natal day 1-3
Secondary outcome [3] 421833 0
Concentration of sulforaphane and metabolites in urine
Timepoint [3] 421833 0
Pre-dose (baseline) At time of caesarean section (at least 2-hours post dose)
Secondary outcome [4] 421834 0
Histological assessment of placenta
Timepoint [4] 421834 0
At least two hours post dose

Eligibility
Key inclusion criteria
- Singleton pregnancy.
- Planned elective caesarean section.
- Gestation greater than 37+0 weeks.
- 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).
- Greater than or equal to 18 years of age.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Major complications of pregnancy including, but not limited to, fetal growth restriction, preeclampsia, gestational diabetes on insulin.
- Renal or hepatic dysfunction.
- Current use of broccoli sprout extract supplement.
- Contraindications to use (e.g., 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 0
Type of endpoint/s
Bio-availability
Statistical methods / analysis
A convenience n-number of 8 has been used based on previous work investigating sulforaphane concentrations in pregnant individuals. Demographics will be reported as median and IOR (25th to 75th centile). Paired t-test will be used if normally distributed pharmacokinetic outcomes to determine statistical significance (p < 0.05). Time to maximum concentration (T max) is presented as median and range and tested with Wilcoxon rank-sum test.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/06/2023
Actual
31/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
8
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24696 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 24697 0
Jessie McPherson Private Hospital - Clayton
Recruitment postcode(s) [1] 40319 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 313814 0
University
Name [1] 313814 0
Monash University
Country [1] 313814 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
246 Clayton Road
CLAYTON VIC 3168
Country
Australia
Secondary sponsor category [1] 315649 0
None
Name [1] 315649 0
Address [1] 315649 0
Country [1] 315649 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312974 0
Monash Health Human Research and Ethics Committee
Ethics committee address [1] 312974 0
Ethics committee country [1] 312974 0
Australia
Date submitted for ethics approval [1] 312974 0
25/11/2022
Approval date [1] 312974 0
24/07/2023
Ethics approval number [1] 312974 0
RES-22-0000-732A

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

Contacts
Principal investigator
Name 126546 0
Dr Neville Fields
Address 126546 0
Monash Medical Centre 246 Clayton Road CLAYTON VIC 3168
Country 126546 0
Australia
Phone 126546 0
+61458 439 896
Fax 126546 0
Email 126546 0
[email protected]
Contact person for public queries
Name 126547 0
Neville Fields
Address 126547 0
The Ritchie Centre 27-31 Wright Street CLAYTON VIC 3168
Country 126547 0
Australia
Phone 126547 0
+61 3 9594 5145
Fax 126547 0
Email 126547 0
[email protected]
Contact person for scientific queries
Name 126548 0
Sarah Marshall
Address 126548 0
The Ritchie Centre Monash University 27-31 Wright Street CLAYTON VIC 3168
Country 126548 0
Australia
Phone 126548 0
+61 3 9594 5145
Fax 126548 0
Email 126548 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Will be made accessible following application to the Chief Principal Investigator and with approval

Conditions for requesting access:
• -

What individual participant data might be shared?
• Individual patient data after publication will be shared following application to the chief investigator. Results will be deidentified and provided for circulating concentration of sulforaphane and metabolites after approval.

What types of analyses could be done with individual participant data?
• Primary outcome of sulforaphane and metabolite concentration in umbilical cord blood

When can requests for individual participant data be made (start and end dates)?
From:
Following publication of the study results with no end date

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Via contact to the study chief principal investigator Dr Neville Fields on email [email protected] or Dr Sarah Marshall on [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.