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

Not Applicable

Terminated

• Conditions: Vitamin D Deficiency
• Interventions: Dietary Supplement: Vitamin D

• Registration Number: NCT02876822
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-08-19
• Study First Submitted QC: 2016-08-19
• Study First Posted: 2016-08-24
• Study Start: 2016-08-26
• Primary Completion: 2017-03-16
• Study Completion: 2017-05-01
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-18
• Last Update Posted: 2020-08-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitamin D	Vitamin D	Enrolled subjects will receive one observed oral vitamin D dose (based on current vitamin D status and rounded to the nearest 5000IU) within 2 weeks prior to their HSCT.

Primary Outcome Measures

Name	Time	Method
Serum 25OHD level	Weekly for 8 weeks

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States