Pilot Study of Fructose for Sickle Cell Crisis
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|ClinicalTrials.gov Identifier: NCT00004797|
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
OBJECTIVES: I. Evaluate the efficacy and tolerability of fructose administered every 6 hours for up to 72 hours to patients in active sickle cell crisis.
II. Obtain tolerability information in selected patients treated with fructose for more than 72 hours.
|Condition or disease||Intervention/treatment|
|Sickle Cell Anemia||Drug: fructose Drug: placebo|
PROTOCOL OUTLINE: In the first part of the study, patients are block-randomized (3:1) to a single intravenous dose of fructose or placebo. The dose of fructose is escalated in each successive group after tolerability data are evaluated.
In the second part of the study, patients are randomly assigned (1:1) to fructose or placebo administered intravenously every 6 hours for 72 hours. The dose of fructose is the highest well-tolerated dose determined in Study 1 or the most tolerated dose for the patient. Patients who just completed Study 1 may participate if they are clearly in a separate crisis and continue to meet entry criteria.
Patients whose symptoms persist for more than 72 hours after fructose or placebo are eligible to receive additional fructose every 6 hours until symptoms subside.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Study Start Date :||August 1995|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004797
|Study Chair:||David Green||Shirley Ryan AbilityLab|