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CompletedNCT00029731Updated Mar 25, 2015

Arginine Treatment of Acute Chest Syndrome (Pneumonia) in Sickle Cell Disease Patients

A Phase 2 interventional study of Arginine hydrochloride in Anemia, Sickle Cell and Pneumonia, sponsored by UCSF Benioff Children's Hospital Oakland. Completed at 1 site in United States. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2015-03-25.

Sponsored by UCSF Benioff Children's Hospital Oakland · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
5 Years and older
Sex
All
01

Study summary

This is a study to determine if oral arginine will increase nitric oxide in sickle cell disease (SCD) patients with acute chest syndrome (ACS). It will also assess the effects of arginine in the body and how the body uses nitric oxide in ACS.

Read the detailed description

Pneumonia in patients with SCD can be particularly severe and has come to be called acute chest syndrome. ACS is a common cause of morbidity in SCD patients and is the most common cause of death in SCD. Multiple factors are involved in the severity of acute pulmonary injury in SCD. Nitric oxide has a multitude of related functions, many of which could impact favorably on ACS in SCD. Nitric oxide is an important inflammatory mediator which is produced by the conversion of L-arginine to citrulline by nitric oxide synthase. Nitric oxide and its precursor, arginine, are known to be low in SCD patients with ACS, suggesting that therapies, such as arginine, aimed at increasing nitric oxide production will improve the clinical course of ACS. Patients will receive 1 of 3 doses of arginine hydrochloride orally 3 times a day for 3 days while hospitalized. The efficacy of arginine will be measured by the increase in nitric oxide production and the physiological effects will be assessed.

Completion date provided represents the completion date of the grant per OOPD records

02

Conditions studied

  • Anemia, Sickle Cell
  • Pneumonia

Keywords

  • Nitric Oxide
  • Administration, Oral
03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's planned enrollment of 30 is below the median of 106 across 1,247 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

UCSF Benioff Children's Hospital Oakland is the lead sponsor of 53 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of sickle cell disease (Hb SS, SC, or Sbeta thalassemia)

Acute chest syndrome with the following:

  • New pulmonary infiltrate on chest radiography involving a full segment of the lung and 1 of the following:
  • Fever
  • Cough, tachypnea, retractions, rales, or wheezing
  • Chest pain

Exclusion criteria

Exclusion criteria:

  • Inability to take or tolerate oral medications
  • Hepatic dysfunction (SGPT greater than 2 times normal)
  • Renal dysfunction (creatinine greater than 2 times normal)
  • Mental status or neurological changes
  • Allergy to arginine
  • History of priapism
  • Pregnancy
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Enrollment
30 participants (estimated)

Interventions

  • DrugArginine hydrochloride
06

Study locations

1 site
  • Children's Hospital Oakland
    Oakland, California 94609, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00029731
Lead sponsor
UCSF Benioff Children's Hospital Oakland
First posted
Jan 22, 2002
Start date
Aug 2001
Completion
Jul 2005
Last update
Mar 25, 2015
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2002. You cannot join it, but the record below documents what was studied.

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