NCT00029731

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2001

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 22, 2002

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
Last Updated

March 25, 2015

Status Verified

January 1, 2002

First QC Date

January 21, 2002

Last Update Submit

March 24, 2015

Conditions

Anemia, Sickle CellPneumonia

Keywords

Nitric OxideAdministration, Oral

Interventions

Arginine hydrochlorideDRUG

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Oakland

Oakland, California, 94609, United States

Location

MeSH Terms

Conditions

Anemia, Sickle CellPneumonia

Interventions

Arginine

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesRespiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, Essential

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 21, 2002

First Posted

January 22, 2002

Study Start

August 1, 2001

Study Completion

July 1, 2005

Last Updated

March 25, 2015

Record last verified: 2002-01

Locations

US(1)