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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 16
Maximum Age: 40
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Kenya
KEMRI Centre for Global Health Research
RECRUITING
Kisumu
Contact Information
Primary
Feiko O. ter Kuile, PhD
feiko.terkuile@lstmed.ac.uk
+441517053287
Backup
Hellen C. Barsosio, MD
hbarsosio@kemri.go.ke
+254724464507
Time Frame
Start Date: 2023-12-29
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 2960
Treatments
Experimental: L-citrulline arm
L-citrulline arm is the intervention arm consisting of a twice daily 6.0 g sachet, each containing 5.000 g of quality-assured L-citrulline powder, 0.672 g maltodextrin and 0.286 g lactose anhydrous, 0.03 g citric acid, 0.012 g lemon flavour + antenatal standard of care with enhanced monitoring. The sachets will be provided at enrolment and each subsequent monthly ANC visit.
No_intervention: Placebo arm
Placebo arm is the control arm consisting of a twice daily 6.0 g sachet of quality-assured placebo, each consisting of 3.6 g maltodextrin and 2.358 g lactose monohydrate, 0.03 g citric acid, 0.012 g lemon flavour + antenatal standard of care with enhanced monitoring. The sachets will be provided at enrolment and each subsequent monthly ANC visit.
Sponsors
Collaborators: Telethon Kids Institute, Kenya Medical Research Institute, University of Toronto
Leads: Liverpool School of Tropical Medicine

This content was sourced from clinicaltrials.gov