NCT06635902 · Suvankar Majumdar
Intravenous L-Citrulline for Vaso-occlusive Pain Episode in Sickle Cell Disease
What this study is about
The goal of this clinical trial is to learn if given through a vein (IV) citrulline works to treat acute pain in hospitalized patients with sickle cell disease. It will also learn about the safety of given through a vein (IV) citrulline.
View original scientific description
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.
Interventions
DRUG
L-citrulline
Intravenous L-citrulline (50 mg/kg + 9mg/kg/hr.) for 16 hours
OTHER
Placebo
Isotonic normal saline
DRUG
L-citrulline
Intravenous L-citrulline (25 mg/kg + 9mg/kg/hr.) for 16 hours
Primary outcome measures
Time-to-crisis resolution
Time frame: Baseline to 30 days
Change in time-to-crisis resolution as defined by the time (in hours) from first dose of intravenous study drug or placebo to the time of last dose of intravenous opioid during hospitalization
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Sickle cell disease (all genotypes)
- Patients with sickle cell disease ages 4 to 21 years old
- Presence of sickle cell vaso-occlusive pain episode requiring hospitalization and parenteral opioid therapy
- Able to randomize to study drug/placebo within 12 hours of first dose of parenteral opioid in the Emergency Department
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
- Presence of acute chest syndrome, sepsis, bacterial infection, hemodynamic instability
- Use of L-glutamine
- History of allergic reaction to L-citrulline products
Where
- Washington D.C., District of Columbia
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 13, 2026 · Source of record for eligibility and locations