L-citrulline supplementation during pregnancy to reduce adverse birth outcomes in Kenyan women at risk of malaria.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

AGREE is an individually randomized, two-arm, placebo-controlled trial enrolling 2,960 pregnant Kenyan women up to 24 weeks' gestation. Participants are randomly assigned to receive either a twice-daily 6.0 g sachet containing 5.00 g L-citrulline plus standard antenatal care or a taste-matched placebo sachet, with monthly visits through delivery. The primary outcome is a composite of fetal loss, preterm birth, small for gestational age, or low birthweight, and the trial includes safety monitoring and assessment of placental development. The trial targets women at high risk of malaria and protein undernutrition and requires ultrasound-confirmed singleton pregnancies and delivery at study clinics.

Why it matters

Who can join: the full rules

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

Where it's running

• KEMRI Centre for Global Health Research
  Kisumu, Kenya Recruiting

Study contacts

• Principal investigator: Kevin Kain, PhD — University of Toronto
• Study coordinator: Feiko O. ter Kuile, PhD
• Email: feiko.terkuile@lstmed.ac.uk
• Phone: +441517053287

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.