We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Arginine Therapy in Sickle Cell Disease-VOC Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01796678
Recruitment Status : Completed
First Posted : February 22, 2013
Last Update Posted : July 31, 2013
Sponsor:
Information provided by (Responsible Party):
UCSF Benioff Children's Hospital Oakland

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Vaso-occlusion contributes significantly to morbidity in sickle cell disease (SCD). Vaso-occlusive painful episodes (VOE) are common and debilitating, causing the majority of emergency department visits. Currently efforts to treat painful episodes with use of non-steroidal pain relievers and intravenous narcotics offer symptomatic relief only, without targeting the underlying mechanisms of vaso-occlusion.Investigators have found that an arginine deficiency and low NO bioavailability occurs during painful events in SCD. Since arginine is the obligate substrate for NO production, and an acute deficiency is associated with VOE, investigators hypothesized that arginine supplementation may be a safe and beneficial treatment for sickle cell pain.

Condition or disease Intervention/treatment Phase
Vaso-occlusive Pain Episodes Drug: Arginine Drug: Placebo Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Arginine Therapy in Sickle Cell Disease-VOC Clinical Trial
Study Start Date : September 2000
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Arginine
100 mg/kg T.I.D 3x a day IV or PO
 Drug: Arginine
Other Name: L-arginine, L-arginine-HCL
Placebo Comparator: Placebo
Saline or sugar pill
 Drug: Placebo
Saline or Sugar pill was given as placebo


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Length of Hospital Stay [ Time Frame: participants will be followed for the duration of hospital stay an expected average of 3-6 days, with re-admission data being collect for up to 30 days ]

Secondary Outcome Measures :
  1. Effect on Pain Score [ Time Frame: participants will be followed for the duration of hospital stay an expected average of 3-6 days ]
  2. Total Opioid Use (mg/kg) [ Time Frame: participants will be followed for the duration of hospital stay an expected average of 3-6 days ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Established Diagnosis of Sickle Cell Disease(SS,SC,S-beta thal)
  • Admitted to Hospital for pain
  • Pain requiring hospitalization for parenteral narcotics, not attributable to non-sickle cell causes
  • >3 year and older

Exclusion Criteria:

  • Hemoglobin less than 5gm/dL or immediate need for red cell transfusion
  • Hepatic Dysfunction: increased in SGPT to >2x normal value
  • Renal Dysfunction: increased in creatinine to >2x normal value or >1.5
  • Mental status or neurological changes
  • Pregnancy
  • >10 Hospitalizations per year or history of dependance to narcotics
  • Inability to take oral medications or allergy to arginine
  • Inability to use a PCA device
  • < 3 years of age
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01796678


Locations
Layout table for location information
United States, California
Childrens Hospital Research Center Oakland
Oakland, California, United States, 94609
Sponsors and Collaborators
UCSF Benioff Children's Hospital Oakland
Investigators
Layout table for investigator information
Principal Investigator: Claudia R Morris, MD Childrens Hospital Oakland
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: UCSF Benioff Children's Hospital Oakland
ClinicalTrials.gov Identifier: NCT01796678    
Other Study ID Numbers: HL 14386-05
First Posted: February 22, 2013    Key Record Dates
Last Update Posted: July 31, 2013
Last Verified: July 2013
Keywords provided by UCSF Benioff Children's Hospital Oakland:
sickle cell disease
vaso-occlusive pain episodes
arginine
nitric oxide
Additional relevant MeSH terms:
Layout table for MeSH terms
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn