Pilot Study of Fructose for Sickle Cell Crisis

Sponsors

Lead Sponsor: National Center for Research Resources (NCRR)

Collaborator: Shirley Ryan AbilityLab

Source Office of Rare Diseases (ORD)
Brief 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.

Overall Status Completed
Start Date August 1995
Phase N/A
Study Type Interventional
Enrollment 20
Condition
Intervention

Intervention Type: Drug

Intervention Name: fructose

Intervention Type: Drug

Intervention Name: placebo

Eligibility

Criteria:

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Sickle cell crisis requiring hospital admission Crisis began at least 12 hours prior to admission Medical records documenting sickle cell disease and previous crisis requiring hospital visit during the last 24 months available at study site No thalassemia No complex hemoglobinopathy involving thalassemia and sickle cell disease

--Patient Characteristics-- Renal: Creatine no greater than 2.2 mg/dL No requirement for regular dialysis Other: Weight above or below 30% of ideal body weight No fructose intolerance No insulin-dependent diabetes No HIV seropositivity No acquired immune deficiency syndrome (AIDS) or AIDS-related illness No general anesthetic for 7 days prior to and 2 days following entry Primary language allows communication with study staff Demonstration of ability to read and understand pain scales required Ability to identify crisis starting time accurately, i.e., to within 6 hours

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
David Green Study Chair Shirley Ryan AbilityLab
Verification Date

December 2001

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Primary Purpose: Treatment

Source: ClinicalTrials.gov