Other Clinical Trial - Ultra-high Dose Vitamin D for HSCT

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Hematopoietic Stem Cell Transplant

Clinical Trial Details

NCT number	NCT03759262
Study type	Interventional
Source	Children's Hospital Los Angeles
Contact
Status	Completed
Phase	Phase 1
Start date	December 10, 2018
Completion date	May 10, 2020

View Details

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