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Completed

NCT Number: NCT03759262

Ultra-high Dose Vitamin D for HSCT

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.

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Key information

Age range

0 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecalciferol

Drug

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.

Other names: vitamin D

Primary outcomes

  1. Incidence of graft-versus-host disease, veno-occlusive disease, and thrombotic microangiopathy

    Time frame: 100 days after transplant

    Graft-versus-host disease, veno-occlusive disease, and thrombotic microangiopathy

  2. Vitamin D sufficiency following Stoss dosing

    Time frame: prior to transplant

    Vitamin D sufficiency following Stoss dosing prior to tranpslantation

Secondary outcomes

  1. Rates of survival, relapse, and significant infections

    Time frame: from time of transplant to 1 year after transplant

    Clinically significant events including but not limited to survival, relapse, significant infections.

  2. Cytokine levels

    Time frame: before vitamin D is given, 1-2 weeks after vitamin D is given, day of transplant, day +7, day +14, and day +30

    The investigators will examine changes in levels of IFN-gamma, TNF-alpha, IL-1a, IL-1b, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10 (in pg/mL) before and after vitamin D is given

  3. Cytokine stimulation test

    Time frame: before vitamin D is given, and 1-2 weeks after vitamin D is given

    The investigators will examine changes in the immune profile (reactivity of CD45, 235, 61, 66 197, 19, 4, 38, 163, 43, 7, 62L, 127, 123, 279, 274, 14, 90, 11c, 294, 15, 16, 25, 27, 8, 33, 3, 45RA, 56, 11b; pS6, p-p38, HLA-DR, pERK 1/2, pStat3, pStat1, TCRgd, pStat5) in response to cytokine stimulation before and after vitamin D is given

Sponsors and collaborators

Lead sponsor

Children's Hospital Los Angeles

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 29, 2018
Registry last updated
May 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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