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

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

Plain Language Summary

Simplified for easier understanding

Preeclampsia is a serious complication of pregnancy characterised by high blood pressure and organ damage, particularly affecting the kidneys and liver. It can progress rapidly and is a leading cause of premature birth and maternal and infant mortality worldwide. Currently, the only definitive treatment is delivery of the baby — sometimes dangerously early — and there are very few medications that can safely be used during pregnancy to treat the underlying problem. Broccoli sprouts contain a natural compound called sulforaphane, which has powerful antioxidant and anti-inflammatory properties that may target some of the biological processes that cause preeclampsia. This early-phase study aims to determine what dose of broccoli sprout extract is appropriate for pregnant women with preeclampsia, as the first step before a larger trial can be conducted. To be eligible you need to be a pregnant woman aged 18 to 45 with a diagnosis of preeclampsia (confirmed by specialist guidelines), be more than 24 weeks pregnant, have a single baby (not twins), and be stable enough to safely continue the pregnancy for at least 48 hours. Women who are not able to safely continue the pregnancy, who have inflammatory bowel disease, or who are enrolled in another clinical trial are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(2)

Monash Medical Centre - Clayton campus - Clayton

VIC, Australia

Jessie McPherson Private Hospital - Clayton

VIC, Australia

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ACTRN12618001655235


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