Arginine Therapy for Pain in Children with Sickle Cell Disease
This study is looking at whether giving extra arginine, a natural amino acid, can help children with sickle cell disease who are experiencing pain crises (vaso-occlusive painful events or VOE). Patients with sickle cell disease often have low levels of arginine, which might be linked to their pain. Researchers want to see if increasing arginine levels through intravenous (IV) infusions can reduce pain, lessen the need for pain medications like morphine, or shorten hospital stays. You might be able to join if you are 7 to 21 years old, have a specific type of sickle cell disease (Hb-SS or Sβᴼ-thalassemia), weigh at least 55 pounds, and are experiencing pain that requires medical care. The study's current status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 21 participants. It is not specified if the study is randomized or blinded.
- What's involved
- You would receive arginine intravenously (in the vein) either three times a day for up to seven days, as an initial dose followed by regular doses, or as a continuous IV infusion. The study will measure your plasma arginine concentration and nitric oxide levels over an average of up to 7 days.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your plasma arginine concentration and nitric oxide metabolites will be measured from Day 1 through study completion, which is an average of up to 7 days.
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Arginine Therapy for the Treatment of Pain in Children With Sickle Cell Disease
At a glance
Conditions
Where it's being run
2 sites across 1 statesStudy leadership
- Claudia Morris, MD · PRINCIPAL_INVESTIGATOR · Emory University
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Pharmacokinetics of IV arginine, measured by plasma arginine concentration over timeDay 1 through study completion, an average of up to 7 days
Total time plasma arginine levels are maintained above the half-saturating concentration (Km) of cationic amino acid transporter protein-1 (CAT-1), which is 150 µM (normal range of extracellular plasma arginine concentration). pK samples will be collected at 6 time-points within 8 hours: prior to arginine treatment (time 0), and at 60, 90, 120 minutes, 4 and 8 hours after the initiation of arginine therapy, and then every 24 hours up to 7 days.
- Change in nitric oxide metabolitesBaseline, day 1 through study completion, an average of up to 7 days
The formation of NO metabolites will be measured by determination of its stable end products in serum; nitrite (NO2-) and nitrate (NO3-). Change in nitric oxide metabolites will be calculated as the difference in metabolites from the time prior to arginine treatment (baseline) to the end of the intervention period.