Effectiveness of Arginine as a Treatment for Sickle Cell Anemia

Completed · Phase 2 · Has a placebo group

Conditions studied: Anemia, Sickle Cell

In brief

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.

Key facts

Study ID

NCT00513617

Run by

UCSF Benioff Children's Hospital Oakland

People needed

128

Starts

2004-06-01

Expected to finish

2008-01-01

Last updated by the study team

2017-03-29

Who can join

Age: 5 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Hospital of Oakland and Research Institute — Oakland, California, United States
• University of California - San Francisco — San Francisco, California, United States
• University of Colorado at Denver and Health Sciences Center--Sickle Cell Treatment and Research Center — Denver, Colorado, United States
• Kosair Children's Hospital — Louisville, Kentucky, United States
• Boston Medical Center — Boston, Massachusetts, United States
• University of Mississippi Medical Center (Adult) — Jackson, Mississippi, United States
• University of Mississippi Medical Center (Pediatric) — Jackson, Mississippi, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Children's Hospital of Montefiore — The Bronx, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Children's Hospital of Oklahoma — Oklahoma City, Oklahoma, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• St. Christopher's Children's Research Hospital — Philadelphia, Pennsylvania, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• St. Jude Children's Research Hospital — Memphis, Tennessee, United States
• Children's Medical Center of Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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