NCT05934318 L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)
| NCT ID | NCT05934318 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Liverpool School of Tropical Medicine |
| Condition | Pregnancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,960 participants |
| Start Date | 2023-12-29 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,960 participants in total. It began in 2023-12-29 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Kevin Kain, PhD
PRINCIPAL INVESTIGATOR
University of Toronto
Frequently Asked Questions
Who can join the NCT05934318 clinical trial?
This trial is open to female participants only, aged 16 Years or older, up to 40 Years, studying Pregnancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05934318 currently recruiting?
Yes, NCT05934318 is actively recruiting participants. Contact the research team at feiko.terkuile@lstmed.ac.uk for enrollment information.
Where is the NCT05934318 trial being conducted?
This trial is being conducted at Kisumu, Kenya.
Who is sponsoring the NCT05934318 clinical trial?
NCT05934318 is sponsored by Liverpool School of Tropical Medicine. The principal investigator is Kevin Kain, PhD at University of Toronto. The trial plans to enroll 2,960 participants.