CO-Sprout-A Pilot Double-Blinded Placebo-Controlled Randomised Trial of Broccoli Sprout Powder Supplementation for Pregnant Women with COVID-19 on the Duration of COVID-19-Associated Symptoms: Study Protocol

Neville J Fields; Kirsten R Palmer; Daniel L Rolnik; Jennifer Yo; Marcel F Nold; Michelle L Giles; Sushena Krishnaswamy; Ary Serpa Neto; Ryan J Hodges; Sarah A Marshall

doi:10.3390/nu15183980

CO-Sprout-A Pilot Double-Blinded Placebo-Controlled Randomised Trial of Broccoli Sprout Powder Supplementation for Pregnant Women with COVID-19 on the Duration of COVID-19-Associated Symptoms: Study Protocol

Nutrients. 2023 Sep 14;15(18):3980. doi: 10.3390/nu15183980.

Authors

Neville J Fields^{1

2}, Kirsten R Palmer^{1

2}, Daniel L Rolnik^{1

2}, Jennifer Yo^{1

2}, Marcel F Nold^{1

3

4}, Michelle L Giles^{1

2}, Sushena Krishnaswamy², Ary Serpa Neto^{5

6

7

8}, Ryan J Hodges^{1

2}, Sarah A Marshall¹

Affiliations

¹ The Ritchie Centre, Department of Obstetrics and Gynaecology, School of Clinical Sciences, Monash University, Melbourne 3168, Australia.
² Monash Health, Monash Medical Centre, Melbourne 3168, Australia.
³ Department of Paediatrics, Monash University, Melbourne 3168, Australia.
⁴ Monash Newborn, Monash Children's Hospital, Melbourne 3168, Australia.
⁵ Australian and New Zealand Intensive Care Research Centre (ANZIC-RC), School of Public Health and Preventive Medicine, Melbourne 3004, Australia.
⁶ Department of Critical Care, Melbourne Medical School, University of Melbourne, Austin Hospital, Melbourne 3084, Australia.
⁷ Department of Intensive Care, Austin Hospital, Melbourne 3084, Australia.
⁸ Department of Critical Care Medicine, Hospital Israelita Albert Einstein, Sao Paulo 05652-900, Brazil.

Abstract

Since its discovery in late 2019, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been estimated to be responsible for at least 769.3 million infections and over 6.95 million deaths. Despite significant global vaccination efforts, there are limited therapies that are considered safe and effective for use in the management of COVID-19 during pregnancy despite the common knowledge that pregnant patients have a much higher risk of adverse outcomes. A bioactive compound found in broccoli sprout-sulforaphane-is a potent inducer of phase-II detoxification enzymes promoting a series of potentially beneficial effects notably as an antioxidant, anti-inflammatory, and anti-viral. A pilot, double-blinded, placebo-controlled randomised trial is to be conducted in Melbourne, Australia, across both public and private hospital sectors. We will assess a commercially available broccoli sprout extract in pregnant women between 20⁺⁰ and 36⁺⁰ weeks gestation with SARS-CoV-2 infection to investigate (i) the duration of COVID-19 associated symptoms, (ii) maternal and neonatal outcomes, and (iii) biomarkers of infection and inflammation. We plan to enrol 60 outpatient women with COVID-19 irrespective of vaccination status diagnosed by PCR swab or RAT (rapid antigen test) within five days and randomised to 14 days of oral broccoli sprout extract (42 mg of sulforaphane daily) or identical microcrystalline cellulose placebo. The primary outcome of this pilot trial will be to assess the feasibility of conducting a larger trial investigating the duration (days) of COVID-19-associated symptoms using a broccoli sprout supplement for COVID-19-affected pregnancies. Pregnant patients remain an at-risk group for severe disease following infection with SARS-CoV-2 and currently unclear consequences for the offspring. Therefore, this study will assess feasibility of using a broccoli sprout supplement, whilst providing important safety data for the use of sulforaphane in pregnancy.

Keywords: COVID-19; SARS-CoV-2; broccoli sprout; clinical trial; pregnancy; sulforaphane.

Publication types

Clinical Trial Protocol

MeSH terms

Brassica*
COVID-19*
Double-Blind Method
Female
Humans
Powders
Pregnancy
Pregnant Women
Randomized Controlled Trials as Topic
SARS-CoV-2
Treatment Outcome

Substances

sulforaphane
Powders

Grants and funding

This research received no external funding. K.R.P. is supported by an NHMRC Investigator Grant (GNT2009765). S.A.M. is supported by an NHMRC Early Career Fellowship (GTN1160684).