The BEET-BP Trial
Research type
Research Study
Full title
The effects of dietary nitrate supplementation on pregnancies complicated by chronic and new onset hypertension
IRAS ID
263871
Contact name
Nikos Kametas
Contact email
Sponsor organisation
King's College Hospital NHS Foundation Trust
Duration of Study in the UK
2 years, 11 months, 30 days
Research summary
Hypertensive diseases of pregnancy (HDP) can be pre-existing (chronic hypertension (CHTN)) or new onset (gestational hypertension (GH)/preeclampsia (PE)). HDP occur on a spectrum, with CHTN and GH having the ability to progress to PE. 30% of those with CHTN will develop superimposed PE, whilst 40% of those with GH will develop PE.
The only cure for PE is delivery of the placenta, and therefore the fetus, resulting in the need to delicately balance the risk of maternal complications against premature delivery.
Studies using dietary nitrate supplementation in the form of beetroot juice (a naturally high nitrate food), have shown to significantly reduce the blood pressure of non-pregnant adults. Two pilot studies carried out in pregnant women, showed beetroot juice to be a safe and acceptable treatment. It is not known whether dietary nitrate supplementation in pregnancy can effectively reduce the progression to and severity of PE in women with HDP.
In this study we will be conducting an England multi-site double-blinded randomised controlled trial investigating the effect of dietary nitrate on women with both chronic and new onset hypertension. The primary outcome of the study is gestational age of delivery with preeclampsia – one of the most important indicators of HDP severity.
Women who present with new or chronic hypertension between 24+0 to 36+6 weeks’ gestation will be recruited. Consenting participants will be randomised to receive either beetroot juice concentrate (intervention) or a dummy juice with the nitrate content removed (placebo). Both juices are made from organic ingredients – beetroot juice (98%) and lemon juice (2%). Participants will take one 70mL juice ‘shot’ per day from recruitment until delivery. They will continue with routine clinical care antenatally and postnatally. Antihypertensive medications will be prescribed as clinically required. Maternal and fetal outcomes in both intervention and placebo groups will be subsequently compared.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
19/WM/0239
Date of REC Opinion
4 Sep 2019
REC opinion
Further Information Favourable Opinion