Oral Antenatal L-citrulline Supplementation to Reduce Adverse Pregnancy Outcomes: a Two-arm, Randomized, Placebo-controlled Multi-site Trial in Kenya

What this Trial Is About

Researchers are studying whether adding L-citrulline, a natural amino acid found in foods, to the diets of pregnant women in Kenya can help improve pregnancy outcomes. This trial focuses on pregnant women at risk of malaria and protein undernutrition, conditions linked to poor birth outcomes like fetal loss, preterm birth, low birth weight, and neonatal death. The primary aim is to see if daily L-citrulline supplements can reduce these adverse outcomes compared to a placebo. The study is a randomized, placebo-controlled trial involving 2,960 pregnant women aged 16 to 40 years with a single viable pregnancy up to 24 weeks gestation. Participants are assigned to take either a twice daily 6.0 g sachet of L-citrulline powder plus standard antenatal care or a placebo sachet without L-citrulline, continuing supplementation until 6 weeks after delivery. All receive enhanced monitoring and standard care during pregnancy. Participants will have monthly visits until delivery, plus follow-up visits at 1 and 6 weeks after birth. Their infants will be monitored at 6, 12, 18, and 24 months. The study measures a composite of adverse pregnancy outcomes as the primary result, and secondary outcomes include markers of placental function, infection, inflammation, and early childhood development. A subset of mother-infant pairs will have their vaginal and intestinal microbiota analyzed. The total participation lasts until the child is 2 years old.

L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)