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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03759262
Other study ID # CHLA-18-00362
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date December 10, 2018
Est. completion date May 10, 2020

Study information

Verified date May 2024
Source Children's Hospital Los Angeles
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


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


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date May 10, 2020
Est. primary completion date May 10, 2020
Accepts healthy volunteers No
Gender All
Age group 0 Years to 25 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • Hematopoietic Stem Cell Transplant

Intervention

Drug:
Cholecalciferol
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.

Locations

Country Name City State
United States Children's Hospital Los Angeles Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
Children's Hospital Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (5)

Caballero-Velazquez T, Montero I, Sanchez-Guijo F, Parody R, Saldana R, Valcarcel D, Lopez-Godino O, Ferra I Coll C, Cuesta M, Carrillo-Vico A, Sanchez-Abarca LI, Lopez-Corral L, Marquez-Malaver FJ, Perez-Simon JA; GETH (Grupo Espanol de Trasplante Hematopoyetico). Immunomodulatory Effect of Vitamin D after Allogeneic Stem Cell Transplantation: Results of a Prospective Multicenter Clinical Trial. Clin Cancer Res. 2016 Dec 1;22(23):5673-5681. doi: 10.1158/1078-0432.CCR-16-0238. Epub 2016 Jun 29. — View Citation

Hansson ME, Norlin AC, Omazic B, Wikstrom AC, Bergman P, Winiarski J, Remberger M, Sundin M. Vitamin d levels affect outcome in pediatric hematopoietic stem cell transplantation. Biol Blood Marrow Transplant. 2014 Oct;20(10):1537-43. doi: 10.1016/j.bbmt.2014.05.030. Epub 2014 Jun 5. — View Citation

van Etten E, Mathieu C. Immunoregulation by 1,25-dihydroxyvitamin D3: basic concepts. J Steroid Biochem Mol Biol. 2005 Oct;97(1-2):93-101. doi: 10.1016/j.jsbmb.2005.06.002. Epub 2005 Jul 19. — View Citation

Wallace G, Jodele S, Howell J, Myers KC, Teusink A, Zhao X, Setchell K, Holtzapfel C, Lane A, Taggart C, Laskin BL, Davies SM. Vitamin D Deficiency and Survival in Children after Hematopoietic Stem Cell Transplant. Biol Blood Marrow Transplant. 2015 Sep;21(9):1627-31. doi: 10.1016/j.bbmt.2015.06.009. Epub 2015 Jun 18. — View Citation

Wallace G, Jodele S, Myers KC, Dandoy CE, El-Bietar J, Nelson A, Teusink-Cross A, Khandelwal P, Taggart C, Gordon CM, Davies SM, Howell JC. Single Ultra-High-Dose Cholecalciferol to Prevent Vitamin D Deficiency in Pediatric Hematopoietic Stem Cell Transplantation. Biol Blood Marrow Transplant. 2018 Sep;24(9):1856-1860. doi: 10.1016/j.bbmt.2018.05.019. Epub 2018 May 18. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of graft-versus-host disease, veno-occlusive disease, and thrombotic microangiopathy Graft-versus-host disease, veno-occlusive disease, and thrombotic microangiopathy 100 days after transplant
Primary Vitamin D sufficiency following Stoss dosing Vitamin D sufficiency following Stoss dosing prior to tranpslantation prior to transplant
Secondary Rates of survival, relapse, and significant infections Clinically significant events including but not limited to survival, relapse, significant infections. from time of transplant to 1 year after transplant
Secondary Cytokine levels 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 before vitamin D is given, 1-2 weeks after vitamin D is given, day of transplant, day +7, day +14, and day +30
Secondary Cytokine stimulation test 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 before vitamin D is given, and 1-2 weeks after vitamin D is given
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