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Arginine Therapy in Sickle Cell Disease-VOC Clinical Trial

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ClinicalTrials.gov Identifier: NCT01796678
Recruitment Status : Completed
First Posted : February 22, 2013
Last Update Posted : July 31, 2013
Sponsor:
Information provided by (Responsible Party):
Children's Hospital & Research Center Oakland

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 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


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




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 ]


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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

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
United States, California
Childrens Hospital Research Center Oakland
Oakland, California, United States, 94609
Sponsors and Collaborators
Children's Hospital & Research Center Oakland
Investigators
Principal Investigator: Claudia R Morris, MD Childrens Hospital Oakland

Publications of Results:
Responsible Party: Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier: NCT01796678     History of Changes
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 Children's Hospital & Research Center Oakland:
sickle cell disease
vaso-occlusive pain episodes
arginine
nitric oxide

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn