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

See also
Status	Clinical Trial	Phase
Withdrawn	`NCT02451462` - Pilot Trial of Zoledronic Acid to Prevent Bone Loss in Hematopoietic Cell Transplant Recipients	N/A
Terminated	`NCT01215981` - Influenza Vaccine Post Allogeneic Transplant	N/A
Recruiting	`NCT03613532` - Venetoclax Added to Fludarabine + Busulfan Prior to Transplant and to Maintenance Therapy for AML, MDS, and MDS/MPN	Phase 1
Completed	`NCT01337648` - Radiation Biodosimetry in Children Undergoing Total Body Irradiation	N/A
Recruiting	`NCT03250546` - Haploidentical and Mismatched Unrelated Donors Hematopoietic Stem Cell Transplant	Phase 2
Recruiting	`NCT02982902` - T Cell Therapy of Opportunistic Cytomegalovirus Infection	Early Phase 1
Completed	`NCT02441075` - 70% Ethanol for Decontamination of CVL Exposed to Calcineurine Inhibitors Version 1.0, 1/9/2014	N/A
Completed	`NCT04549038` - Time Restricted Nutrition in Pediatric Stem Cell Transplant Recipients	N/A
Completed	`NCT03886909` - Impact of Prehabilitation in Oncology Via Exercise- Bone Marrow Transplant	N/A
Not yet recruiting	`NCT05722210` - Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Not yet recruiting	`NCT06328127` - Positive Psychology Intervention for Hematopoietic Stem Cell Transplantation Survivors	N/A
Completed	`NCT03509051` - Prospective Study on the Vaccine Response to Meningococcal B Vaccine After Allogeneic Stem Cell Transplantation	N/A
Terminated	`NCT02350777` - T-cell Depleted Hematopoietic Stem Cell Boosts Without Conditioning for Poor Marrow Graft Function Following Allogeneic Hematopoietic Stem Cell Transplantation	Phase 2
Completed	`NCT04853277` - Patient Reported Outcomes and Patient Education in Cellular Therapy Patients	N/A
Completed	`NCT03378089` - Music Therapy and Hematopoietic Stem Cell Transplant	N/A
Completed	`NCT03039257` - Vitamin A Replacement in Patients Undergoing HSCT and Its Role on MBI-LCBI Rates	N/A
Completed	`NCT03202849` - A Randomized Trial of Vitamin D Supplementation With or Without Vitamin A in Stem Cell Transplantation	N/A
Completed	`NCT01581164` - Studies of the Immune Response to Vaccination After Hematopoietic Stem Cell Transplantation	N/A
Completed	`NCT01504152` - International Travel Patterns and Health Preparations of Hematopoietic Stem Cell Transplant Recipients at Memorial Sloan-Kettering Cancer Center	N/A
Recruiting	`NCT04263597` - Oral Supplementation of 2'-Fucosyllactose in Allogeneic Bone Marrow Transplant Recipients	Phase 1/Phase 2