Ultra-high Dose Vitamin D for HSCT
- Registration Number
- NCT03759262
- Lead Sponsor
- Children's Hospital Los Angeles
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Vitamin D (Cholecalciferol) Cholecalciferol All subjects will be enrolled to this arm. A single dose of ultra-high-dose vitamin D will be given.
- Primary Outcome Measures
Name Time Method Incidence of graft-versus-host disease, veno-occlusive disease, and thrombotic microangiopathy 100 days after transplant Graft-versus-host disease, veno-occlusive disease, and thrombotic microangiopathy
Vitamin D sufficiency following Stoss dosing prior to transplant Vitamin D sufficiency following Stoss dosing prior to tranpslantation
- Secondary Outcome Measures
Name Time Method Cytokine levels 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
Cytokine stimulation test 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
Rates of survival, relapse, and significant infections from time of transplant to 1 year after transplant Clinically significant events including but not limited to survival, relapse, significant infections.
Trial Locations
- Locations (1)
Children's Hospital Los Angeles
🇺🇸Los Angeles, California, United States