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RECRUITING
NCT05636397
NA

Safety and PK-PD Study of Oral L-CIT in Preterm Infants with BPD±PH and NEC

Sponsor: The Hospital for Sick Children

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety and explore the PK/PD of L-CIT supplementation in preterm infants to prevent the development of inflammatory pathways initiated by low levels of plasma CIT, specifically in preterm infants with post surgical NEC and BPD±PH.

Official title: A Phase I, Safety and Pharmacokinetics/pharmacodynamics Study of Oral L-CIT Supplementation in Preterm Infants with BPD±PH and NEC

Key Details

Gender

All

Age Range

1 Month - 6 Months

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2023-11-01

Completion Date

2028-03

Last Updated

2025-01-16

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

L-Citrulline

Citrulline is a nonessential amino acid made in the small intestine, occurs naturally in the body, and is believed to help reduce inflammation.L-CIT is a part of the urea cycle, produced as a by-product along with nitric oxide (NO).

Locations (1)

The Hospital For Sick Children

Toronto, Ontario, Canada