CO-Sprout: Broccoli sprout powder pilot trial for COVID-19 positive pregnant women on the duration of symptoms

CO-Sprout: A pilot double-blinded randomised control trial of broccoli sprout powder supplementation for pregnant women with COVID-19 on the duration of symptoms

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12622000173796

Acronym

CO-Sprout

Enrollment

Registered

2022-02-02

Start date

2022-08-23

Completion date

2023-06-14

Last updated

2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

CO-Sprout clinical trial will investigate whether broccoli sprout powder capsules given to pregnant women infected with SARS-CoV-2 (COVID-19) can help reduce the duration of COVID-19 associated symptoms. Additional outcomes measured will include hospital admissions, maternal respiratory outcomes, obstetric and birthing outcomes, as well as neonatal outcomes. It is hoped that providing pregnant women with this natural supplement during COVID-19 infection, will help reduce the levels of inflammation and improve their symptoms hopefully leading to reduced need for hospital and ICU admissions. Broccoli sprout powder contains the naturally occurring phytonutrient sulforaphane which is hoped to improve maternal and neonatal outcomes during pregnancy from infection with the SARS-CoV-2 virus.

Interventions

Broccoli sprout powder capsules (producing 21mg sulforaphane) Oral 2 capsules (10.5mg sulforaphane) twice a day, morning and night (BD). Total daily dose 42mg of sulforaphane daily The administration of the trial intervention will cease after 14 days of treatment or in the event the patient is unable to continue oral supplementation Adherence to trial intervention will be measured by return of capsules at end of trial and with use of a study participant drug diary

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

• Currently pregnant with singleton gestation from 20+0 - 36+0 weeks • Positive COVID-19 test including (viral polymerase chain reaction (PCR) positive test for SARS-CoV-2) or positive rapid antigen test (RAT) within 5 days • Unvaccinated, partially, fully (+/- booster dose) vaccinated against COVID-19 • Signs or symptoms of COVID-19 that began less than or equal to 7 days of trial recruitment including but not limited to shortness of breath, anosmia, fevers, sore throat, headache and myalgia • Able to tolerate oral supplementation and willing to complete the expected 14 day course • 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

Exclusion criteria

• Current use of broccoli or broccoli sprout 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 PICF (patient information consent form) • 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, antiviral, immunomodulatory or complementary and alternative medicines) • Current antibiotic, antiviral or monoclonal antibody treatment related to acute illness at time of recruitment

Outcome results