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

NCT ID: NCT03320915

Last Updated: 2017-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Hematologic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cholecalciferol

Cholecalciferol 5mg (200,000 IU)

Group Type EXPERIMENTAL

Cholecalciferol

Intervention Type DRUG

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

Usual care

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cholecalciferol

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

Intervention Type DRUG

Other Intervention Names

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Caldiferol

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Youngil Koh

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Youngil Koh, M.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jae Hyun Kim

Role: CONTACT

Phone: 82-2-2072-0335

Email: [email protected]

Facility Contacts

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Youngil Koh, M.D.

Role: primary

Other Identifiers

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H-1702-040-830

Identifier Type: -

Identifier Source: org_study_id