Effectiveness of Arginine as a Treatment for Sickle Cell Anemia

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI); UCSF Benioff Children's Hospital Oakland
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)

Criteria

Inclusion Criteria:

• Established diagnosis of H SS or S-beta thalassemia

• History of at least one vaso-occlusive pain event in the 12 months prior to study entry

• Regular compliance with comprehensive medical care

• In a steady disease state and not in the midst of any acute complication due to SCD at study entry

Exclusion Criteria:

• Inability to take or tolerate oral medications

• Liver dysfunction (i.e., SGPT level greater than or equal to two times the normal limit and albumin level less than or equal to 3.2 g/dL)

• Kidney dysfunction ( i.e., creatinine level greater than or equal to 1.2 mg/dL for children and greater than or equal to 1.4 mg/dL for adults)

• Allergy to arginine

• Pregnant

• Received a blood transfusion within the 90 days prior to study entry

• More than 10 hospital admissions for pain in the 12 months prior to study entry

• Daily use of opioids and experiencing unstable pain that interferes with work or daily routine

• Required more than 3 hospital admissions and more than 10 emergency department/day hospital visits in the 12 months prior to study entry

• Received treatment with hydroxyurea within the 90 days prior to study entry

• Received treatment with any investigational drug in the 90 days prior to study entry