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CHronic hypERtension and L-citRulline studY (CHERRY): an Early-Phase Randomised Controlled Trial in Pregnancy.

  • 2023-10-03
  • Reproductive sciences (Thousand Oaks, Calif.) 31(2)
    • Laura Ormesher
    • Stephanie A Worton
    • Ashley Best
    • Susanna R Dodd
    • Alice Dempsey
    • Elizabeth C Cottrell
    • Heather Glossop
    • Catherine Chmiel
    • Hoi Yee Wu
    • Ben Hardwick
    • Sophie Hennessy
    • Edward D Johnstone
    • Jenny E Myers

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 24
Population
Pregnant women with chronic hypertension
Methods
early-phase randomised feasibility trial; randomised at 12-16 weeks to receive 3-g L-citrulline twice daily (n=24) or placebo (n=12) for 8 weeks
Duration
8 weeks
Oral supplementation with L-citrulline, which is sequentially converted to L-arginine then nitric oxide, improves vascular biomarkers and reduces blood pressure in non-pregnant, hypertensive human cohorts and pregnant mice with a pre-eclampsia-like syndrome. This early-phase randomised feasibility trial assessed the acceptability of L-citrulline supplementation to pregnant women with chronic hypertension and its effects on maternal BP and other vascular outcomes. Pregnant women with chronic hypertension were randomised at 12-16 weeks to receive 3-g L-citrulline twice daily (n = 24) or placebo (n = 12) for 8 weeks. Pregnant women reported high acceptability of oral L-citrulline. Treatment increased maternal plasma levels of citrulline, arginine and the arginine:asymmetric dimethylarginine ratio, particularly in women reporting good compliance. L-citrulline had no effect on diastolic BP (L-citrulline: - 1.82 95% CI (- 5.86, 2.22) vs placebo: - 5.00 95% CI (- 12.76, 2.76)), uterine artery Doppler or angiogenic biomarkers. Although there was no effect on BP, retrospectively, this study was underpowered to detect BP changes < 9 mmHg, limiting the conclusions about biological effects. The increase in arginine:asymmetric dimethylarginine ratio was less than in non-pregnant populations, which likely reflects altered pharmacokinetics of pregnancy, and further pharmacokinetic assessment of L-citrulline in pregnancy is advised.Trial Registration EudraCT 2015-005792-25 (2017-12-22) and ISRCTN12695929 (2018-09-20).

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