Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00513617
Status:
COMPLETED
Last Update Posted:
2017-03-29
First Post:
2007-08-06
Brief Title:
Effectiveness of Arginine as a Treatment for Sickle Cell Anemia
Sponsor:
UCSF Benioff Childrens Hospital Oakland
Organization:
UCSF Benioff Childrens Hospital Oakland
Study Overview
Official Title:
Arginine Supplementation in Sickle Cell Anemia Physiological and Prophylactic Effects
Status:
COMPLETED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Arginine
Brief Summary:
Sickle cell disease SCD also known as sickle cell anemia is an inherited genetic disease that can cause intense pain episodes This study will evaluate the effectiveness of the nutritional supplement arginine at improving blood cell function and disease symptoms in people with SCD
Detailed Description:
SCD is an inherited blood disorder Symptoms include anemia infections organ damage and intense episodes of pain that are called sickle cell crises SCD is caused by an abnormal type of hemoglobin which is a protein inside red blood cells that carries oxygen In people with SCD the abnormal hemoglobin distorts the shape of the red blood cells This causes the red blood cells to clump together decreasing blood flow and oxygen delivery to the bodys tissues The reduced levels of oxygen can lead to sickle cell crises and tissue damage Hemolysis the destruction of red blood cells is also a hallmark of SCD During hemolysis hemoglobin is released into the bloodstream where it removes nitric oxide NO a natural chemical in the body that expands blood vessels Arginase another protein released during hemolysis removes arginine from the bloodstream which can also lead to decreased NO levels The lack of NO constricts blood vessels further contributing to painful sickle cell crises Arginine supplementation may increase healthy hemoglobin and NO production and in turn prevent or reduce sickle cell crises The purpose of this study is to evaluate the effectiveness of arginine at increasing NO levels improving red blood cell function and reducing hospitalizations and pain medication use in people with SCD
This study will enroll children and adults with SCD Participants will be randomly assigned to receive twice daily doses of either a low dose of arginine a high dose of arginine or placebo for 12 weeks Study visits will occur at baseline three times during Month 1 and Weeks 8 12 14 and 16 Each study visit will include an echocardiogram to measure heart activity blood collection and a medical history review to identify adverse events pain medication usage headaches emergency department visits and hospitalizations
This study will enroll children and adults with SCD Participants will be randomly assigned to receive twice daily doses of either a low dose of arginine a high dose of arginine or placebo for 12 weeks Study visits will occur at baseline three times during Month 1 and Weeks 8 12 14 and 16 Each study visit will include an echocardiogram to measure heart activity blood collection and a medical history review to identify adverse events pain medication usage headaches emergency department visits and hospitalizations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U54HL070587-04 | NIH | None | httpsreporternihgovquickSearchU54HL070587-04 |