Efficacy and Safety of High Dose Vitamin D Supplementation in Patients Undergoing HSCT

Efficacy and Safety of High Dose Vitamin D Supplementation in Patients Undergoing Hematopoietic Stem Cell Transplantation

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03320915

Enrollment

Registered

2017-10-25

Start date

2017-10-01

Completion date

2019-12-31

Last updated

2017-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematologic Neoplasms

Brief summary

Graft-versus-host-disease (GVHD) is common complication of hematopoietic stem cell transplantation. Vitamin D deficiency has been shown to be associated with increased risk of chronic GVHD in previous clinical studies. The purpose of this research is to investigate the effect of vitamin D supplementation in patients undergoing hematopoietic stem cell transplantation

Detailed description

Hematopoietic stem cell transplant candidates are randomized to vitamin D supplementation or usual care. Five milligrams (200,000 IU) of cholecalciferol is injected to intervention group before stem cell transplantation. Additional supplementation of cholecalciferol during follow-up period is determined according to the level of 25(OH)D3. The primary outcome is the incidence of chronic GVHD which is determined according to IBMTR criteria. The secondary outcome consists of the incidence of acute GVHD, incidence and severity of vitamin D deficiency, and serum concentration of 25(OH)D3. Study investigators expect that supplementation of vitamin D may improve the outcome of stem cell transplantation by reducing the incidence of chronic GVHD.

Interventions

DRUGCholecalciferol

Cholecalciferol 5mg (200,000 IU) up to maximum of three times during 1 year follow-up period according to measured 25(OH)D3 level.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adults with ≥ 18 years old * Diagnosed with hematologic maligancies * Planned to undergo allogeneic stem cell transplantation

Exclusion criteria

* Hypercalcemia (ionized serum calcium level \[iCa\] \> 1.3 mmol/L, corrected serum calcium level \> 10.5 mg/dL) * Impaired renal function (Serum creatinine ≥ 2.4 mg/dL) * Not in complete remssion (except for myelodysplastic syndrome and myeloproliferative neoplasm) * Consent withdrawal * Considered inadequate under investigator's discretion

Design outcomes

Primary

Measure	Time frame	Description
Chronic GVHD	Up to 1 year	Events will be graded according to IBMTR criteria

Secondary

Measure	Time frame	Description
Acute GVHD	Up to 100 days	Events will be graded according to IBMTR criteria
Vitamin D deficiency	Up to 1 year	Severity and incidence of Vitamin D deficiency
25(OH)D3	Up to 1 year	Serum concentration of 25(OH)D3

Countries

South Korea

Contacts

Primary ContactJae Hyun Kim

jaerung90@gmail.com82-2-2072-0335

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026