RecruitingPhase 1ACTRN12618001655235

Pharmacokinetics of broccoli sprout extract in preeclampsia.

Investigating the pharmacokinetic profile of broccoli sprout extract in women with preeclampsia.

Sponsor

Monash Health

Enrollment

18 participants

Start Date

Mar 26, 2019

Study Type

Interventional

Conditions

Preeclampsia

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.

Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 45 Yearss

Inclusion Criteria9

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 Criteria8

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)

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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 ea

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.