NCT03613727

Therapeutic Use of Intravenous Vitamin C in Allogeneic Stem Cell Transplant Recipients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years – 77 Years
• Healthy volunteers: Not accepted

Summary

This phase 2 trial studies the effect of intravenous (IV) vitamin C repletion after myeloablative allogeneic stem cell transplant.

Detailed description

Vitamin C is a nutritional supplement that can help fight inflammation. Most patients who have a stem cell transplant have lower than normal levels of vitamin C in their blood. Patients will receive intravenous Vitamin C the day after transplant for two weeks, followed by oral vitamin C until six months after transplant. The effect of the Vitamin C on non-relapse mortality (NRM), time to engraftment, rate of acute graft-versus-host disease and to characterize the safety and tolerability of the vitamin C regimen.

Conditions

• Lymphoid Leukemia
• Myeloid Leukemia
• Monocytic Leukemia
• Myelodysplasia

Interventions

Type	Name	Description
DRUG	Intravenous (IV) and oral Vitamin C	Intravenous (IV) vitamin C 50 mg/kg/day divided in 3 doses beginning on posttransplant Day +1 and continuing through Day +14; each dose (16.7 mg/kg) given in 50 mL of 5% dextrose and water over 30 minutes every 8 hours • After completion of the IV vitamin C doses, oral vitamin C 500 mg twice each day beginning on Day +15 and continuing until Day +180

Timeline

• Start date: 2018-10-01
• Primary completion: 2022-10-06
• Completion: 2022-10-06
• First posted: 2018-08-03
• Last updated: 2023-11-07
• Results posted: 2023-11-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study