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
| Type | Name | Description |
|---|---|---|
| DRUG | Arginine | |
| DRUG | Placebo | Saline 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.