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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: Completed Phase 1 study, sponsored by The University of Texas Medical Branch, Galveston.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
L-arginine and citrulline levels in the plasma will be measured via liquid chromatography-mass spectroscopy (LCMS) and a change (increase) in plasma levels of 20% on day 7 from baseline on day 0 will be considered significant.
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 |
What the finished NCT03649932 record still lists
NCT03649932 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 1 intervention - of which Enteral L-citrulline is the first listed.
NCT03649932 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03649932's enrollment target sits among peer trials
42 1105th of 2000 higher than 876 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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