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Amino Acid Supplement

L-Citrulline for Sickle Cell Disease

Phase 2
Recruiting
Led By Suvankar Majumdar, MD
Research Sponsored by Suvankar Majumdar
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Sickle cell disease (all genotypes)
Patients with sickle cell disease ages 4 to 21 years old
Must not have
Current pain lasting >3 days
More than 9 hospitalizations in the prior year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 30 days

Summary

This trial aims to investigate if intravenous citrulline can help reduce acute pain in hospitalized patients with sickle cell disease. Researchers will compare the effects of intravenous citrulline to a

Who is the study for?
This trial is for hospitalized patients with sickle cell disease experiencing acute pain episodes. Participants must be willing to receive intravenous treatment and return for a follow-up visit after discharge.
What is being tested?
The study tests if intravenous L-citrulline can reduce the duration of pain during hospitalization for sickle cell crises compared to a placebo, along with assessing its safety.
What are the potential side effects?
Potential side effects are not detailed here, but the study will monitor any medical problems that arise from taking intravenous L-citrulline.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have sickle cell disease.
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I am between 4 and 21 years old with sickle cell disease.
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I have been hospitalized for sickle cell pain and needed strong painkillers.
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I can start the study drug or placebo within 12 hours after receiving opioid pain medication in the ER.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been experiencing pain for more than 3 days.
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I was hospitalized more than 9 times last year.
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My kidney function, based on my age, meets the study's requirements.
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I am currently taking L-glutamine.
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I have been hospitalized for a sickle cell complication like stroke or organ issues.
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I have a history of opioid use or need opioids daily for chronic pain.
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My liver enzymes are more than twice the normal level.
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I am currently experiencing a severe chest infection, blood infection, or instability in my blood pressure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time-to-crisis resolution
Secondary study objectives
Opioid consumption
Pain scores
Safety
Other study objectives
Citrulline and arginine bioavailability
Cytokine interleukin IL-1ß
Genetic
+2 more

Side effects data

From 2019 Phase 3 trial • 189 Patients • NCT02891837
18%
Pyrexia
14%
Pain
13%
Hypertension
12%
Tachycardia
12%
Hypokalaemia
11%
Constipation
11%
Restlessness
8%
Haemoglobin decreased
8%
Pleural effusion
7%
Hypocalcaemia
7%
Tachypnoea
5%
Vomiting
5%
Electrolyte imbalance
5%
Cough
5%
Pulmonary congestion
5%
Hypotension
4%
Metabolic acidosis
4%
Hypomagnesaemia
4%
Stridor
4%
Oligurea
4%
Atelectasis
4%
Leukocytosis
3%
Anaemia
3%
Sinus bradycardia
3%
Diarrhoea
3%
Post procedural haemorrhage
3%
Blood pressure decreased
3%
Coagulation time prolonged
3%
Pulmonary oedema
3%
Haematocrit decreased
1%
Ventricular tachycardia
1%
Arrhythmia
1%
Staphylococcal infection
1%
Cardiac tamponade
1%
Ventricular fibrillation
1%
Leukopenia
1%
Thrombocytopenia
1%
Aortic valve incompetence
1%
Atrioventricular block complete
1%
Nausea
1%
Peripheral swelling
1%
Blood lactic acid increased
1%
C-reactive protein increased
1%
Chylothorax
100%
80%
60%
40%
20%
0%
Study treatment Arm
L-citrulline - All Patients on Mechanical Ventilation for ≤48 Hours
L-citrulline - All Patients
L-citrulline - US Patients on Mechanical Ventilation for >48 Hours
Placebo - All Patients
L-citrulline - US Patients on Mechanical Ventilation for ≤48 Hours
L-citrulline - All Patients on Mechanical Ventilation for >48 Hours
Placebo - All Patients on Mechanical Ventilation for ≤48 Hours
Placebo - US Patients on Mechanical Ventilation for ≤48 Hours
Placebo - All Patients on Mechanical Ventilation for >48 Hours
Placebo - US Patients on Mechanical Ventilation for >48 Hours

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Low dose intravenous L-citrullineExperimental Treatment1 Intervention
Group II: High dose intravenous L-citrullineExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
L-citrulline
2010
Completed Phase 3
~530

Find a Location

Who is running the clinical trial?

Suvankar MajumdarLead Sponsor
1 Previous Clinical Trials
4 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,935 Previous Clinical Trials
47,792,232 Total Patients Enrolled
Suvankar Majumdar, MDPrincipal InvestigatorChildren's National Research Institute
~66 spots leftby Jun 2028
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