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Arginine Therapy in Sickle Cell Disease-VOC Clinical Trial

Sponsor
UCSF Benioff Children's Hospital Oakland (Other)
Overall Status
Completed
CT.gov ID
NCT01796678
Collaborator
(none)
56
Enrollment
1
Location
2
Arms
81
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
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 :
Sep 1, 2000
Actual Primary Completion Date :
Jun 1, 2007
Actual Study Completion Date :
Jun 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arginine

100 mg/kg T.I.D 3x a day IV or PO

Drug: Arginine
Other Names:
  • L-arginine, L-arginine-HCL

    		•
    Placebo Comparator: Placebo

    Saline or sugar pill

    Drug: Placebo
    Saline or Sugar pill was given as placebo

    Outcome Measures

    Primary Outcome Measures

    1. Length of Hospital Stay [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 [participants will be followed for the duration of hospital stay an expected average of 3-6 days]

    2. Total Opioid Use (mg/kg) [participants will be followed for the duration of hospital stay an expected average of 3-6 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 21 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Childrens Hospital Research Center Oakland Oakland California United States 94609

    Sponsors and Collaborators

    • UCSF Benioff Children's Hospital Oakland

    Investigators

    • Principal Investigator: Claudia R Morris, MD, Childrens Hospital Oakland

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    UCSF Benioff Children's Hospital Oakland
    ClinicalTrials.gov Identifier:
    NCT01796678
    Other Study ID Numbers:
    • HL 14386-05
    First Posted:
    Feb 22, 2013
    Last Update Posted:
    Jul 31, 2013
    Last Verified:
    Jul 1, 2013
    Keywords provided by UCSF Benioff Children's Hospital Oakland
    sickle cell disease
    vaso-occlusive pain episodes
    arginine
    nitric oxide
    Additional relevant MeSH terms:
    Anemia, Sickle Cell

    Study Results

    No Results Posted as of Jul 31, 2013