Back to resultsL-Arginine and Sickle Cell Disease
Primary Purpose
Sickle Cell Disease
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
L-arginine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Sickle Cell Disease focused on measuring sickle cell disease, L-arginine, hemolysis, nitric oxide, pulmonary arterial hypertension
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of sickle cell disease confirmed through hemoglobin electrophoresis
- Genotypes SS, SC and Sβ thalassemia
- Age > 1 year
Exclusion Criteria:
- Liver dysfunction (alanine aminotransferase ALT > 3 times the normal levels
- Renal dysfunction (creatinine > twice the normal levels)
- Increase in methemoglobin levels (> 5 times the normal levels)
- History of recent stroke (< 1 month) and priapism
- Pregnancy
- Allergy to L-arginine
- Use of sildenafil, calcium channel blockers, nitroglycerin or other nitrates
Sites / Locations
- Hospital de Clínicas de Porto Alegre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
L-arginine
Arm Description
0.1g/kg/day for 6 months
Outcomes
Primary Outcome Measures
Tricuspid regurgitant jet velocity >2.5 m/s
Tricuspid regurgitant jet velocity was used to assess pulmonary arterial hypertension before and after treatment with L-arginine.
Secondary Outcome Measures
Lactate dehydrogenase levels
The effect of L-argigine administration on hemolysis was assessed through the variation of serum levels of lactate dehydrogenase.
Full Information
NCT ID
NCT01142219
First Posted
June 10, 2010
Last Updated
June 10, 2010
Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Fundo de Incentivo à Pesquisa do Hospital de Clinicas de Porto Alegre (FIPE), Associação de Amigos da Hematologia (HEMOAMIGOS), Ajinomoto Interamericana Indústria e Comércio Ltda. (donation of L-arginine)
1. Study Identification
Unique Protocol Identification Number
NCT01142219
Brief Title
L-Arginine and Sickle Cell Disease
Official Title
A Randomized, Controlled, Double-blind Clinical Trial of L-arginine as Adjuvant Therapy for Sickle Cell Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Fundo de Incentivo à Pesquisa do Hospital de Clinicas de Porto Alegre (FIPE), Associação de Amigos da Hematologia (HEMOAMIGOS), Ajinomoto Interamericana Indústria e Comércio Ltda. (donation of L-arginine)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
One of the main problems in sickle cell disease is the decreased bioavailability of nitric oxide and arginine. This study was designed to assess if treating sickle cell disease patients with L-arginine would improve pulmonary arterial pressure and other aspects.
Detailed Description
This is a phase III, randomized, double-blind, placebo-controlled clinical trial with sickle cell disease patients older than 1 year of age. The patients were randomly assigned to take 0.1 g/kg/day of either L-arginine or placebo orally. Adverse events were monitored by a safety committee. The variables were assessed while patients were in remission, as part of their routine care: weight, blood pressure, full blood cell count, creatinine and dosage of methemoglobin at baseline and at each follow-up visit. Peripheral oxygen saturation (SpO2), fetal hemoglobin, lactate dehydrogenase and tricuspid regurgitant jet velocity were measured through transthoracic Doppler echocardiogram before and after treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease
Keywords
sickle cell disease, L-arginine, hemolysis, nitric oxide, pulmonary arterial hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
L-arginine
Arm Type
Experimental
Arm Description
0.1g/kg/day for 6 months
Intervention Type
Drug
Intervention Name(s)
L-arginine
Intervention Description
L-arginine was administered orally at a dose of 0.1g/kg/day during 6 months.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Mannitol was administered orally at a dose of 01 g/kg/day for six months.
Primary Outcome Measure Information:
Title
Tricuspid regurgitant jet velocity >2.5 m/s
Description
Tricuspid regurgitant jet velocity was used to assess pulmonary arterial hypertension before and after treatment with L-arginine.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Lactate dehydrogenase levels
Description
The effect of L-argigine administration on hemolysis was assessed through the variation of serum levels of lactate dehydrogenase.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of sickle cell disease confirmed through hemoglobin electrophoresis
Genotypes SS, SC and Sβ thalassemia
Age > 1 year
Exclusion Criteria:
Liver dysfunction (alanine aminotransferase ALT > 3 times the normal levels
Renal dysfunction (creatinine > twice the normal levels)
Increase in methemoglobin levels (> 5 times the normal levels)
History of recent stroke (< 1 month) and priapism
Pregnancy
Allergy to L-arginine
Use of sildenafil, calcium channel blockers, nitroglycerin or other nitrates
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-001
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
L-Arginine and Sickle Cell Disease
We'll reach out to this number within 24 hrs