Ultra-high Dose Vitamin D for HSCT

NCT03759262 | Completed Phase 1 FDA Drug

• 1 other identifier: CHLA-18-00362
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic Stem Cell Transplant

Keywords

vitamin D; cytokines

Outcome Measures

Primary Outcomes (2)

• 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

• Vitamin D sufficiency following Stoss dosing

  Vitamin D sufficiency following Stoss dosing prior to tranpslantation

  prior to transplant

Secondary Outcomes (3)

• Rates of survival, relapse, and significant infections

  from time of transplant to 1 year after transplant

• 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

• Cytokine stimulation test

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

Study Arms (1)

Vitamin D (Cholecalciferol)

EXPERIMENTAL

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

Drug: Cholecalciferol

Interventions

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.

Also known as: vitamin D

Vitamin D (Cholecalciferol)

Eligibility Criteria

• Age: 0 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Related Publications (5)

• 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.

  PMID: 26093045 BACKGROUND

• 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.

  PMID: 29782992 BACKGROUND

• 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.

  PMID: 24910378 BACKGROUND

• 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.

  PMID: 27358490 BACKGROUND

• 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.

  PMID: 16046118 BACKGROUND

MeSH Terms

Interventions

Cholecalciferol; Vitamin D

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Etan Orgel, MD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 29, 2018
• Study Start: December 10, 2018
• Primary Completion: May 10, 2020
• Study Completion: May 10, 2020
• Last Updated: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)