Ultra-high Dose Vitamin D for HSCT



Status:Recruiting
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 25
Updated:3/1/2019
Start Date:December 10, 2018
End Date:February 2020
Contact:Sandy Tran
Email:satran@chla.usc.edu
Phone:(323) 361-4229

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Trial Summary
Trial Overview
Inclusion Criteria

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

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.

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

Inclusion Criteria:

- Patients who are preparing for HSCT

- 25OHD level ≤50 ng/mL

- If a patient is receiving an autologous transplant, enrollment must occur prior to
first transplant in the case that the patient is planned for multiple transplants

Exclusion Criteria:

- Uncorrected hypocalcemia or hypophosphatemia

- Patients in the ICU or on renal replacement therapy

- Patients who have had an allogeneic transplant within the past 12 months prior to
enrollment
We found this trial at
1
site
Childrens Hospital Los Angeles
4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Principal Investigator: Sonata Jodele, MD
Phone: 323-361-4229
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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Los Angeles, CA
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