Intravenous L-Citrulline for Vaso-occlusive Pain Episode in Sickle Cell Disease (NCT06635902)
🩺 Plain-English Summary (8th-Grade Level)
The goal of this clinical trial is to learn if intravenous citrulline works to treat acute pain in hospitalized patients with sickle cell disease. It will also learn about the safety of intravenous citrulline. The main questions it aims to answer are: * Does intravenous citrulline decrease the duration of sickle cell pain during hospitalization * What medical problems do participants have when taking intravenous citrulline? Researchers will compare intravenous citrulline to a placebo (a look-alike substance that contains no drug) to see if intravenous citrulline works to treat acute pain. Participants will: * Receive baseline tests and intravenous citrulline for 16 hours during the hospital stay * After hospital discharge, visit the clinic in about 30 days for checkup and tests
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (15 items).
Location: Children's National Hospital — Washington D.C., District of Columbia
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Current pain lasting \>3 days.
- \>9 hospitalizations in the prior year
- Presence of any other complication related to sickle cell disease requiring the hospitalization such as splenic sequestration, hepatic sequestration, stroke, transient ischemic attack, etc.
- History of opioid use disorder, chronic pain or medical regimen requiring daily opioid use.
- Severe anemia (hemoglobin \<6g/dL)
- Pregnant (as confirmed by a positive urine pregnancy test) or lactating female.
- Alanine/aspartate transferase \>2x upper limit of normal laboratory range for age.
- Subject has the following serum creatinine:
- Age 4 to 13 years \> 0.9 mg/dL
- Age 14 to 17 years 1.0 mg/dL
- Age ≥18 years \>1.5mg/dL
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Children's National Hospital — Washington D.C., District of Columbia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.