Arginine Therapy in Sickle Cell Disease-VOC Clinical Trial

Phase 2

Completed

• Conditions: Vaso-occlusive Pain Episodes
• Interventions: Drug: Arginine; Drug: Placebo

• Registration Number: NCT01796678
• Lead Sponsor: UCSF Benioff Children's Hospital 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-09
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Study First Submitted: 2013-02-19
• Study First Submitted QC: 2013-02-20
• Study First Posted: 2013-02-22
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-29
• Last Update Posted: 2013-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arginine	Arginine	100 mg/kg T.I.D 3x a day IV or PO
Placebo	Placebo	Saline or sugar pill

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Effect on Pain Score	participants will be followed for the duration of hospital stay an expected average of 3-6 days
Total Opioid Use (mg/kg)	participants will be followed for the duration of hospital stay an expected average of 3-6 days

Trial Locations

Locations (1)

Childrens Hospital Research Center Oakland; 🇺🇸 Oakland, California, United States