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Completed

NCT Number: NCT01796678

Arginine Therapy in Sickle Cell Disease-VOC Clinical Trial

Vaso-occlusion contributes significantly to morbidity in sickle cell disease (SCD). Vaso-occlusive painful episodes (VOE) are common and debilitating, causing the majority of emergency department visits. Currently efforts to treat painful episodes with use of non-steroidal pain relievers and intravenous narcotics offer symptomatic relief only, without targeting the underlying mechanisms of vaso-occlusion.Investigators have found that an arginine deficiency and low NO bioavailability occurs during painful events in SCD. Since arginine is the obligate substrate for NO production, and an acute deficiency is associated with VOE, investigators hypothesized that arginine supplementation may be a safe and beneficial treatment for sickle cell pain.

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Key information

Conditions

Vaso-occlusive Pain Episodes Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

3 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Childrens Hospital Research Center Oakland

Oakland, California, 94609, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Established Diagnosis of Sickle Cell Disease(SS,SC,S-beta thal)
  • Admitted to Hospital for pain
  • Pain requiring hospitalization for parenteral narcotics, not attributable to non-sickle cell causes
  • >3 year and older

Exclusion criteria

  • Hemoglobin less than 5gm/dL or immediate need for red cell transfusion
  • Hepatic Dysfunction: increased in SGPT to >2x normal value
  • Renal Dysfunction: increased in creatinine to >2x normal value or >1.5
  • Mental status or neurological changes
  • Pregnancy
  • >10 Hospitalizations per year or history of dependance to narcotics
  • Inability to take oral medications or allergy to arginine
  • Inability to use a PCA device
  • < 3 years of age

Treatment and study plan

Arginine

Drug

Other names: L-arginine, L-arginine-HCL

Placebo

Drug

Saline or Sugar pill was given as placebo

Primary outcomes

  1. Length of Hospital Stay

    Time frame: participants will be followed for the duration of hospital stay an expected average of 3-6 days, with re-admission data being collect for up to 30 days

Secondary outcomes

  1. Effect on Pain Score

    Time frame: participants will be followed for the duration of hospital stay an expected average of 3-6 days

  2. Total Opioid Use (mg/kg)

    Time frame: participants will be followed for the duration of hospital stay an expected average of 3-6 days

Sponsors and collaborators

Lead sponsor

UCSF Benioff Children's Hospital Oakland

Other

Registry information

Important dates

Study start
2000
Primary completion
2007
Study completion
2007
First posted
Feb 22, 2013
Registry last updated
Jul 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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