High Dose Vitamin D Replacement in Patients Undergoing Hematopoietic Stem Cell Transplantation

Vitamin D Deficiency Clinical Trial

Official title:

Safety and Efficacy of Single, High Dose Vitamin D Replacement in Patients Undergoing Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02876822
• Other study ID #: 2016-2193
• Status: Terminated
• Phase: N/A
• Start date: August 26, 2016
• Est. completion date: May 1, 2017

Study information

• Verified date: August 2020
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the efficacy and safety of high dose vitamin D therapy among HSCT patients in a tiered, step-wise manner (step one/two) in order to define treatment doses capable of providing vitamin D sufficiency.

Description:

Vitamin D deficiency is common in childhood and has been associated with increased incidence of graft versus host disease (GVHD) and decreased survival in patients undergoing hematopoietic stem cell transplantation (HSCT). Recently, quality improvement efforts to correct serum vitamin D levels among inpatients at CCHMC who have already received HSCT and who were vitamin D deficient suggest that current recommended doses of vitamin D are inadequate to treat vitamin D deficiency. Possible hindrances to vitamin D treatment in the HSCT population include malabsorption related to gut GVHD, mucositis, increased requirement for calcium and/or vitamin D, kidney disease, liver disease, and infection. Single, high dose vitamin D treatment (stoss-therapy) has been utilized effectively to treat rickets and other chronic illnesses such as cystic fibrosis in children. The investigators hypothesize that stoss-therapy provided orally prior to transplantation will result in rapid and sustained correction of vitamin D deficiency in children who require HSCT. The investigators propose to test the efficacy and safety of high dose vitamin D therapy among HSCT patients in a tiered, step-wise manner (step one/two) in order to define treatment doses capable of providing vitamin D sufficiency.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: May 1, 2017
• Est. primary completion date: March 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Step 1: Patients who are preparing for HSCT, 25OHD level (<50 ng/mL), and no prior history of HSCT.

• Step 2: Patients who are preparing for HSCT 25OHD level (<50 ng/mL).

Exclusion Criteria (both Step 1 and Step 2):

• Patients with history of pathologic fractures,

• uncorrected hypocalcemia or hypophosphatemia,

• known history of nephrocalcinosis or nephrolithiasis,

• current granulomatous disease,

• those currently in ICU.

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Vitamin D

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum 25OHD level		Weekly for 8 weeks