Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001100381p
Ethics application status
Submitted, not yet approved
Date submitted
26/07/2017
Date registered
28/07/2017
Date last updated
23/06/2020
Date data sharing statement initially provided
23/06/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Pharmacokinetics of Sulforaphane from Natural Broccoli Sprout Supplements in Pregnancy.
Scientific title
Pharmacokinetics of Sulforaphane from Natural Broccoli Sprout Supplements in Pregnancy: a prospective, open label trial.
Secondary ID [1] 292496 0
Nil known
Universal Trial Number (UTN)
U1111-1199-6883
Trial acronym
Linked study record
This trial is linked with ANZCTR, ACTRN:12617000567325

Health condition
Health condition(s) or problem(s) studied:
Pre-eclampsia. 304130 0
Condition category
Condition code
Reproductive Health and Childbirth 303462 303462 0 0
Normal pregnancy
Reproductive Health and Childbirth 303463 303463 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will be administered:
Supplement name: BroccoMax Broccoli Seed Extract (Myrosinase activated) . Delayed release. Manufacturer: Jarrow Formulas
Sulforaphane glucosinolate content 30mg per tablet (capsule)
1) Single dose (2 capsules)
2) The mode of administration: oral
Intervention code [1] 298676 0
Treatment: Other
Comparator / control treatment
The trial is the partner of our other ANZCTR study: ACTRN 12617000567325. The trial recruited n=6 non pregnant, healthy participants (3 male and 3 female). These 6 non-pregnant participants were given 2 different broccoli spout supplements in order to ascertain which one elevated serum sulforaphane levels the most. The results generated from the study, recruitment & data collection period: June 2017 to July 2017, have been used in the design of the study which will now be undertaken in pregnant women and will form a historical control group.
Control group
Historical

Outcomes
Primary outcome [1] 302835 0
The primary outcome of the trial is to ascertain the serum level of sulforaphane following the ingestion of a broccoli sprout supplement in healthy, pregnant women.
Timepoint [1] 302835 0
Blood samples will be collected from participants for pharmacokinetic (PK) analysis: before ingestion of the supplement (5 minutes, or less) and then following ingestion of the supplement, at a 'desired' eight further targeted time points of: 15 (+/-5) minutes, 30 (+/-5) minutes, 60 (+/-5) minutes, 90 (+/-5) minutes, 120 (+/-15) minutes, 240 (+/-15) minutes, 480 (+/-15) minutes and 720 (+/-15) minutes.
Secondary outcome [1] 337196 0
To compare the data with that obtained previously from a healthy, non pregnant population who were administered the same supplement (ANZCTR, ACTRN:12617000567325).
Timepoint [1] 337196 0
At the time of data analysis, once all the Ok sampling and laboratory analysis of blood samples has been completed.

Eligibility
Key inclusion criteria
Healthy, pregnant with a singleton fetus between 24 to 36 weeks gestation.

Able to read and understand the Patient Information and Consent Form, and to provide written, informed consent.
Minimum age
18 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnant women who are taking a medication, or who have a medical or pregnancy related condition, that may have the potential to interfere with the pharmacokinetics of the broccoli sprout supplement.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis
The study is an exploratory study to obtain Pk data related to the ingestion of broccoli sprout supplements, the n=6 participants was chosen based on the data available from previous, similar studies.
Participant demographic data will be assessed for normality. Characteristics of the two groups will be tabulated and compared using the appropriate statistical test (e.g. Chi 2, independent t-test, Mann-Whitney test). Nonparametric data will be expressed as median and interquartile range (IQR). A p-value <0.05 (two-tailed) will be regarded as statistically signi cant. Data will be analysed using the SPSS statistical package (SPSS 24.0, IBM Corp, Armonk, New York, USA).
PK data will analysed by nonlinear mixed-effects modelling.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Prior to HREC approval, the project was developed further and has now been undertaken as a PhD project. ACTRN12618001655235.
Date of first participant enrolment
Anticipated
4/02/2019
Actual
Date of last participant enrolment
Anticipated
31/12/2019
Actual
Date of last data collection
Anticipated
4/02/2020
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 8584 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 16692 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 297067 0
University
Name [1] 297067 0
Monash University
Country [1] 297067 0
Australia
Funding source category [2] 297071 0
Other
Name [2] 297071 0
The Hudson Institute of Medical Research, The Ritchie Centre
Country [2] 297071 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address
Monash Medical Centre
246 Clayton Road
Clayton
Victoria 3168
Country
Australia
Secondary sponsor category [1] 296074 0
None
Name [1] 296074 0
Address [1] 296074 0
Country [1] 296074 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 298248 0
Monash Health, Human Research Ethics Committee
Ethics committee address [1] 298248 0
Ethics committee country [1] 298248 0
Australia
Date submitted for ethics approval [1] 298248 0
03/08/2017
Approval date [1] 298248 0
Ethics approval number [1] 298248 0

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

Contacts
Principal investigator
Name 76466 0
Prof Euan M. Wallace
Address 76466 0
Department of Obstetrics and Gynaecology, Monash University
Monash Medical Centre
246 Clayton Road
Clayton
Victoria 3168
Country 76466 0
Australia
Phone 76466 0
+61 3 9594 5145
Fax 76466 0
+61 3 9594 5003
Email 76466 0
[email protected]
Contact person for public queries
Name 76467 0
Ms Yizhen Liu
Address 76467 0
The Ritchie Centre, Hudson Institute of Medical Research and Department of Obstetrics and Gynaecology, Monash University
Monash Medical Centre
246 Clayton Road
Clayton.
Victoria 3168
Country 76467 0
Australia
Phone 76467 0
+61 3 8572 2840
Fax 76467 0
+61 3 9594 6811
Email 76467 0
[email protected]
Contact person for scientific queries
Name 76468 0
Euan M. Wallace
Address 76468 0
Department of Obstetrics and Gynaecology, Monash University
Monash Medical Centre
246 Clayton Road
Clayton
Victoria 3168
Country 76468 0
Australia
Phone 76468 0
+61 3 9594 5145
Fax 76468 0
+61 3 9594 5003
Email 76468 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
The trial has been withdrawn prior to HREC approval. Therefore, there will be no data to share, because the trial did not start.


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.