Actively Recruiting
Intravenous L-Citrulline for Vaso-occlusive Pain Episode in Sickle Cell Disease
Led by Suvankar Majumdar · Updated on 2026-04-13
99
Participants Needed
1
Research Sites
218 weeks
Total Duration
On this page
Sponsors
S
Suvankar Majumdar
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Intravenous L-Citrulline for Vaso-occlusive Pain Episode in Sickle Cell Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of sickle cell disease (all genotypes)
- Age between 4 and 21 years
- Currently experiencing a sickle cell vaso-occlusive pain episode requiring hospitalization and parenteral opioid therapy
- Able to start study drug/placebo within 12 hours of first parenteral opioid dose in the Emergency Department
You will not qualify if you...
- Pain lasting more than 3 days at enrollment
- More than 9 hospitalizations in the previous year
- Hospitalization due to other sickle cell complications like splenic or hepatic sequestration, stroke, or transient ischemic attack
- History of opioid use disorder, chronic pain, or daily opioid use
- Severe anemia with hemoglobin less than 6 g/dL
- Pregnant or breastfeeding females
- Elevated liver enzymes (alanine/aspartate transferase more than twice the upper normal limit for age)
- Elevated serum creatinine above age-specific limits
- Presence of acute chest syndrome, sepsis, bacterial infection, or hemodynamic instability
- Current use of L-glutamine
- History of allergic reaction to L-citrulline products
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
Research Team
J
Jillian Baker, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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