Using intravenous L-citrulline to treat pain in sickle cell disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness and safety of intravenous L-citrulline in treating acute vaso-occlusive pain episodes in hospitalized patients with sickle cell disease. Participants aged 4 to 21 years will be randomized to receive either high-dose L-citrulline, low-dose L-citrulline, or a placebo alongside standard care. The primary outcome is the time-to-crisis resolution, measured from the first dose of the study drug to the last dose of parenteral opioids before discharge. Participants will also be monitored for adverse events and will return for follow-up 30 days post-discharge.

Why it matters

Who can join: the full rules

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 it's running

• Children's National Hospital
  Washington D.C., District of Columbia, United States Recruiting

Study contacts

• Principal investigator: Suvankar Majumdar, MD — Children's National Research Institute
• Study coordinator: Jillian Baker, RN
• Email: jbaker5@childrensnational.org
• Phone: 202-476-1311

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.