Ultra-high Dose Vitamin D for HSCT

Children's Hospital Los Angeles

Status and phase: Completed; Phase 1

Conditions: Hematopoietic Stem Cell Transplant

Treatments: Drug: Cholecalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT03759262

CHLA-18-00362

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: Under 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who are preparing for HSCT
• 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

Enrolled patients with 25OHD level ≤50 ng/mL continue on study

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Vitamin D (Cholecalciferol)

Experimental group

Description:

All subjects will be enrolled to this arm. A single dose of ultra-high-dose vitamin D will be given.

Treatment:

Drug: Cholecalciferol