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Trials / Completed

CompletedNCT01796678

Arginine Therapy in Sickle Cell Disease-VOC Clinical Trial

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
56 (actual)
Sponsor
UCSF Benioff Children's Hospital Oakland · Academic / Other
Sex
All
Age
3 Years – 21 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGArginine
DRUGPlaceboSaline or Sugar pill was given as placebo

Timeline

Start date
2000-09-01
Primary completion
2007-06-01
Completion
2007-06-01
First posted
2013-02-22
Last updated
2013-07-31

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01796678. Inclusion in this directory is not an endorsement.

Arginine Therapy in Sickle Cell Disease-VOC Clinical Trial (NCT01796678) · Clinical Trials Directory