L-Arginine and Sickle Cell Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2009-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sickle Cell Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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L-arginine

0.1g/kg/day for 6 months

Group Type EXPERIMENTAL

L-arginine

Intervention Type DRUG

L-arginine was administered orally at a dose of 0.1g/kg/day during 6 months.

Placebo

Intervention Type DRUG

Mannitol was administered orally at a dose of 01 g/kg/day for six months.

Interventions

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L-arginine

L-arginine was administered orally at a dose of 0.1g/kg/day during 6 months.

Intervention Type DRUG

Placebo

Mannitol was administered orally at a dose of 01 g/kg/day for six months.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No