L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Pregnancy, Malaria, Nutrition, Placental Development, Preterm Birth, Fetal Growth Restriction

In brief

There are few safe, effective, and affordable interventions to improve pregnancy outcomes in low resource settings where the highest rates of poor birth outcomes occur. L-citrulline is naturally found in many foods and is changed into another important amino acid, L-arginine, in the body. L-arginine is important for the growth of a healthy placenta and healthy baby. Adding L-citrulline to the diets of pregnant women may be an effective and affordable way to improve the health of their babies.The goal of the AGREE trial is to test whether a dietary supplement containing a common food component, an amino acid called L-citrulline, can help pregnant Kenyan women at risk of malaria have healthier pregnancies and healthier babies. 2,960 pregnant Kenyan women will be enrolled and randomly assigned to take either a twice daily dietary supplement containing L-citrulline or a placebo supplement without additional L-citrulline. Maternal participants will be seen every month until delivery and at weeks 1 and 6 after birth. Infants will also be followed up at ages 6, 12, 18, and 24 months. The primary outcome of the study is 'adverse pregnancy outcome', a composite of foetal loss (miscarriage or still birth), preterm birth, low birth weight, small for gestational age or neonatal mortality. The results of the AGREE trial could help to guide obstetric and public health policy and provide a sustainable solution that could be implemented at the community level.

Key facts

Study ID

NCT05934318

Run by

Liverpool School of Tropical Medicine

People needed

2960

Starts

2023-12-29

Expected to finish

2026-12-30

Last updated by the study team

2025-06-27

Who can join

Age: 16 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• KEMRI Centre for Global Health Research — Kisumu, Kenya (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.