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NCT03649932 · ClinicalTrials.gov registry record · Phase 1
Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing
A Phase 1 study, sponsored by The University of Texas Medical Branch, Galveston.
- Completed
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT03649932 is a Phase 1 study that has completed, run by The University of Texas Medical Branch, Galveston. The registered enrollment target is 42 participants.
The verdict
NCT03649932, a Phase 1 study, has completed, sponsored by The University of Texas Medical Branch, Galveston.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
Study Summary
Oral L-citrulline supplementation may prevent and/or decrease the severity of chronic lung disease associated with pulmonary hypertension in preterm infants. Since oral L-citrulline supplementation has never been studied in preterm infants before, the side effect profile and appropriate dosing are still unknown. In this pilot study, the investigators will determine the safety profile, efficacy and appropriate dosing of oral L-citrulline in preterm infants. In the future, information from this study will be utilized to conduct a randomized placebo-controlled trial to evaluate the role of L-citrulline supplementation in treating BPD\_PH.
Interventions
- DIETARY_SUPPLEMENT Enteral L-citrulline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2018-09-25 |
| Est. Completion | 2021-06-21 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03649932
The ClinicalTrials.gov registry entry for NCT03649932 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Medical Branch, Galveston, which has 203 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Enteral L-citrulline is the first listed.
NCT03649932 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03649932 about?
NCT03649932 is a clinical study titled "Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing". Oral L-citrulline supplementation may prevent and/or decrease the severity of chronic lung disease associated with pulmonary hypertension in preterm infants. Since oral L-citrulline supplementation has never been studied in preterm infants before, the side effect profile and appropriate dosing are s...
What is the current status of trial NCT03649932?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2018-09-25. Estimated completion is 2021-06-21.
What interventions are being tested in trial NCT03649932?
The interventions under investigation include: Enteral L-citrulline (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03649932?
This trial is sponsored by The University of Texas Medical Branch, Galveston, which has 203 total clinical trials registered on ClinicalTrials.gov.
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