ORCHARD BEET: A Feasibility Trial of Dietary Nitrate in CKD Pregnancy

• Research type

  Research Study

• Full title

  Observational cohort with embedded Randomised Controlled trials to study pregnancy-Associated progression of Renal Disease – A Feasibility Study of Dietary Nitrate (BEETroot juice) to protect kidney function in pregnant women with Chronic Kidney Disease

• IRAS ID

  263698

• Contact name

  Kate Bramham

• Contact email

  kate.bramham@kcl.ac.uk

• Sponsor organisation

  King’s College Hospital NHS Foundation Trust

• ISRCTN Number

  ISRCTN91211980

• Duration of Study in the UK

  years, 36 months, days

• Research summary

  Women with kidney disease have worse pregnancy outcomes than healthy women and may require dialysis or lose at least 25% of kidney function during or after pregnancy. Dialysis has considerable impact on the mother, her family and NHS cost.
  Nitric oxide is a substance that helps with many body functions including blood vessel and kidney health. Low nitric oxide may stop kidneys coping with pregnancy. Dietary nitrate (beetroot juice) increases nitric oxide levels and may protect the kidneys from damage in pregnancy.

  Who can participate?
  Adult women, with chronic kidney disease (Stage 2 to 5) before 24 weeks pregnant with one baby, and not established on dialysis.

  What does the study involve?
  Participants are randomly allocated to dietary nitrate (beetroot juice) or standard care. All are seen regularly by healthcare professionals and asked to give blood, urine, saliva and tongue scraping samples, usually at the same time that their routine blood tests are performed. These samples are used to measure substances at the end of the study to see how dietary nitrate works.

  Possible benefits and risks of participating?
  The study will tell us how many women are willing to take part, how women felt about the trial and tolerability of dietary nitrate. These will be used to plan a bigger study to test whether treatments can protect kidney function in pregnancy. Risks of dietary nitrate are expected to be minimal as it has been well tolerated in previous studies of pregnant women.

  Where is the study run from?
  The lead centre for the trial is King's College Hospital. The maternity units in Manchester, Leicester, Nottingham, Royal London, Imperial, Birmingham Women's, Guy's and St Thomas' Hospital are also taking part.

  When is the study starting and how long is it expected to run for?
  36 months from Feb 2020

• REC name

  London - City & East Research Ethics Committee

• REC reference

  20/LO/0009

• Date of REC Opinion

  20 Jan 2020

• REC opinion

  Favourable Opinion