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Study Detail

Study ID 1023
Name Comprehensive Sickle Cell Centers' (CSCC) -Arginine Supplementation in Sickle Cell Anemia: Physiological and Prophylactic Effects
Contact Email lstyles@mail.cho.org
Acronym CSCC-Arginine
Period 2004 - 2007
Design Clinical Trial
Study PI Lori Styles
Institution Childrens Hospital of Oakland and Research Institute
URL https://clinicaltrials.gov/ct2/show/NCT00513617
CTGovID https://clinicaltrials.gov/ct2/show/NCT00513617
Funding Agency NHLBI
Grant Number 5U54HL070587-04
Overview Nitric oxide is an important inflammatory mediator produced from arginine by nitric oxide synthase.Nitric oxide has a multitude of functions which could impact favorably on vaso-occlusion in sickle cell disease.Oral arginine has been shown to raise levels of nitric oxide. This study will test whether daily oral arginineresults in an increase in nitric oxide and other beneficial effects in patients with sickle cell disease. The results ofthis study will serve as the basis for further clinical trials to determine if daily arginine is a beneficial therapy forpatients with sickle cell disease.
Focus Areas 1. To assess the physiological effects (both beneficial and deleterious) of the administrationof oral arginine in patients with SCD.
2. To evaluate the effect of daily oral arginine on clinical vaso-occlusive events in SCDpatients.
Outcomes 1. Efficacy will be determined by changes in three laboratory parameters which will serve assurrogates for potential clinical benefit: nitric oxide, Gardos channel activity, and RBC density.
2. sVCAM, Nitrotyrosine, 8-iso-PGF2a, Ektacytometry, endothelin-1, fetal hemoglobin (HbF) and echocardiogram results as well as clinical outcomes including hospitalizations, ER visits, and painmedication use.
Data Location RTI International
Biospecimen Available Blood; Plasma; Serum; Urine;
Data Consent Consent describes the extent to which confidentiality of records identifying the volunteer will be maintained.
Biospecimen Consent NA
Contact Consent NA
Genomic Data No
Age Range 5-99
No. Participants 128
Inclusion Criteria History of at least one pain event in last 12 months
Exclusion Criteria Major organ dysfunction, treatment with hydroxyurea or transfusion within 3months, history of recent priapism or retinopathy, pregnancy.
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