None listed
Conditions
Brief summary
Preeclampsia is a condition of pregnancy that causes serious health problems to women and their babies. It is important to investigate new medications that could help these women and there babies. One possible option is a natural antioxidant found in broccoli sprout. This study aims to determine the appropriate dose of broccoli sprout extract for pregnant women, so that we can conduct a larger clinical trial investigating this compound.
Interventions
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®) (eac
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.
Sponsors
Monash Health
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
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
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)
Outcome results
None listed