Arginine Therapy in Sickle Cell Disease-VOC Clinical Trial
Completed · Phase 2 · Has a placebo group
Conditions studied: Vaso-occlusive Pain Episodes
In brief
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.
Key facts
- Study ID
- NCT01796678
- Run by
- UCSF Benioff Children's Hospital Oakland
- People needed
- 56
- Starts
- 2000-09-01
- Expected to finish
- 2007-06-01
- Last updated by the study team
- 2013-07-31
Who can join
Age: 3 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Childrens Hospital Research Center Oakland — Oakland, California, United States
Full record on ClinicalTrials.gov
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