L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)

Launched by LIVERPOOL SCHOOL OF TROPICAL MEDICINE · Jun 28, 2023

Keywords

ClinConnect Summary

The AGREE trial is studying whether a dietary supplement called L-citrulline can help improve the health of pregnant women and their babies in Kenya, particularly those at risk of malaria. L-citrulline is a substance found in many foods that the body turns into another important nutrient called L-arginine, which is vital for healthy pregnancy and placental growth. The trial will involve 2,960 pregnant women, who will be divided into two groups: one will receive the L-citrulline supplement twice a day, and the other will receive a placebo (a harmless pill with no active ingredients). Researchers will monitor the women throughout their pregnancies and after childbirth to see if the supplement helps reduce risks such as miscarriages, preterm births, and low birth weights.

To participate in this trial, women should be aged between 16 and 40, be pregnant with a single baby (not twins or triplets), and be willing to follow the study's schedule. They must also be residents of the study area and willing to deliver at a designated clinic or hospital. Women with certain health conditions, like severe anemia or diabetes, or those who are HIV-positive, are not eligible to join. This trial aims to find a safe and affordable way to improve pregnancy outcomes, which could ultimately benefit many families and communities.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Pregnant women aged 16-40 years,
• • inclusive to 24 weeks gestational age as confirmed by ultrasound,
• • who have a viable singleton pregnancy,
• • are residents of the study area,
• • willing to adhere to scheduled and unscheduled study visit procedures,
• • willing to deliver in a study clinic or hospital
• Exclusion Criteria:
• • multiple pregnancies (i.e. twin/triplets);
• • pre-existing hypertension, renal disease and/or diabetes, or severe anaemia (Hb \< 5 g/dL);
• • HIV-positive or HIV status unknown;
• • malformations or nonviable pregnancy observed on enrolment ultrasound;
• • known allergy or contraindication to any of the study supplements including lactose intolerance or observing a lactose-free diet;
• • unable to give consent; or concurrent participation in any other clinical trial