L-Arginine and Sickle Cell Disease
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|ClinicalTrials.gov Identifier: NCT01142219|
Recruitment Status : Completed
First Posted : June 11, 2010
Last Update Posted : June 11, 2010
|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Disease||Drug: L-arginine Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized, Controlled, Double-blind Clinical Trial of L-arginine as Adjuvant Therapy for Sickle Cell Disease|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||January 2008|
|Actual Study Completion Date :||October 2009|
0.1g/kg/day for 6 months
L-arginine was administered orally at a dose of 0.1g/kg/day during 6 months.
Mannitol was administered orally at a dose of 01 g/kg/day for six months.
- Tricuspid regurgitant jet velocity >2.5 m/s [ Time Frame: 6 months ]Tricuspid regurgitant jet velocity was used to assess pulmonary arterial hypertension before and after treatment with L-arginine.
- Lactate dehydrogenase levels [ Time Frame: 6 months ]The effect of L-argigine administration on hemolysis was assessed through the variation of serum levels of lactate dehydrogenase.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01142219
|Hospital de Clínicas de Porto Alegre|
|Porto Alegre, RS, Brazil, 90035-001|