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

NCT ID: NCT02876822

Last Updated: 2020-08-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-26
• Study Completion Date: 2017-05-01

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.

Conditions

Vitamin D Deficiency

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DIETARY_SUPPLEMENT

Interventions

Vitamin D

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

cholecalciferol

Eligibility Criteria

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

• Patients with history of pathologic fractures,
• uncorrected hypocalcemia or hypophosphatemia,
• known history of nephrocalcinosis or nephrolithiasis,
• current granulomatous disease,
• those currently in ICU.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan Howell, MD

Role: PRINCIPAL_INVESTIGATOR

Cincinnati Children's Hosptial Medical Center

Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

2016-2193

Identifier Type: -

Identifier Source: org_study_id