NCT00004797

Pilot Study of Fructose for Sickle Cell Crisis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (planned)
• Sponsor: National Center for Research Resources (NCRR) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Sickle Cell Anemia

Interventions

Type	Name	Description
DRUG	fructose
DRUG	placebo

Timeline

• Start date: 1995-08-01
• First posted: 2000-02-25
• Last updated: 2005-06-24