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Randomized Trial of Dietary Nitrate Supplementation in CKD Pregnancy (ORCHARD-BEET)
Priscilla Smith1, Danielle Ashworth1, Rachel Hung1
1Department of Women's and Children's Health, King's College London, London UK.
Introduction:
Nearly half of pregnant women with moderate-to-severe chronic kidney disease (CKD) will require dialysis or lose ≥ 25% kidney function by 12 months after delivery with high rates of neonatal complications. No targeted approaches have been developed to improve maternal outcomes.
Methods:
Pregnant women with stage G2 to G5 CKD (< 25 weeks' gestation) at 8 centers in the UK were randomized to standard care or daily beetroot juice (dietary nitrate 400 mg) within an observational cohort. Exclusions were established dialysis, age < 18 years, major congenital fetal abnormality, multifetal pregnancy, and beetroot allergy. The primary outcome was recruitment rate/site/mo. Secondary outcomes included feasibility measures as well as maternal and fetal or neonatal clinical and safety events.
Results:
108 participants were randomized (54/arm); overall mean recruitment rate was 1.01/site/mo (SD: 0.90). Women receiving dietary nitrate with prepregnancy estimated glomerular filtration rate (eGFR) < 45 ml/min per 1.73 m2 tended to have lower median creatinine (Cr) concentrations postpartum than those on standard care (6 weeks: Cr, 176 [interquartile range, IQR: 165-194] μmol/l vs. 226 [IQR: 169-296] μmol/l, P = 0.23; 6 months: Cr, 173 [IQR: 152-175] μmol/l vs. 216 [IQR: 149-295] μmol/l, P = 0.18). Admission to a neonatal unit or neonatal intensive care unit (NICU) tended to be lower with dietary nitrate than with standard care (7/30 [23.3%] vs. 21/53 [39.6%], P = 0.13). Seven women receiving dietary nitrate (23.3%) experienced 11 serious adverse events (AEs, SAEs) compared with 27 women receiving standard care (50.9%) who had 53 SAEs (P = 0.02). In post hoc analysis, fewer participants in the dietary nitrate group took antihypertensive medications during pregnancy (11/30 [36.7%] vs. 35/53 [66.0%], P = 0.01).
Conclusion:
We successfully recruited to a multicenter interventional study of pregnant people with CKD with suggestion of maternal kidney and neonatal benefit. Further evidence of efficacy is needed from a powered randomized controlled trial.
