NCT03759262

Ultra-high Dose Vitamin D for HSCT

Pilot Study of Transplant-related Events in Patients Receiving Ultra-high-dose Vitamin D Supplementation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Children's Hospital Los Angeles · Academic / Other
• Sex: All
• Age: 0 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot study to investigate the effects of achieving adequate vitamin D levels via ultra-high-dose vitamin D supplementation given prior to hematopoietic stem cell transplant on transplant-related complications and inflammatory biomarkers.

Detailed description

Up to 70% of patients have vitamin D deficiency prior to hematopoietic stem cell transplant (HSCT). Patients with sufficient Vitamin D levels (\>50nm/L) prior to allogeneic transplant have significantly better overall survival (OS) and lower rates of rejection and relapse. Vitamin D inhibits Th1 and augments Th2 cell development. Patients who receive vitamin D supplementation during allogeneic transplant have less inflammatory-mediated processes such as chronic graft versus host disease (GVHD) and lower levels of naïve CD8+ cells and CD40 ligand. Multiple studies have raised concern regarding the adequacy of standard and high-dose vitamin D dosing for vitamin D deficiency. A single oral ultra-high dose of Vitamin D given prior to HSCT has been shown to be a safe and well tolerated method of sustaining therapeutic Vitamin D levels for 6-19 weeks. This is a pilot study to investigate the dynamic changes in inflammatory biomarkers following ultra-high-dose vitamin D supplementation. The study population is patients with total vitamin D level \</=50ng/mL prior to HSCT.

Conditions

• Hematopoietic Stem Cell Transplant

Interventions

Type	Name	Description
DRUG	Cholecalciferol	A single dose of ultra-high-dose vitamin D (cholecalciferol) will be given prior to hematopoietic stem cell transplant. Research labs including inflammatory biomarker panels will be obtained prior to and after the dose is given.

Timeline

• Start date: 2018-12-10
• Primary completion: 2020-05-10
• Completion: 2020-05-10
• First posted: 2018-11-29
• Last updated: 2024-05-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study