ClinicalTrials.gg
Status unknownNCT03320915Updated Oct 25, 2017

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

A Phase 2 interventional study of Cholecalciferol in Hematologic Neoplasms, sponsored by Seoul National University Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-25.

Sponsored by Seoul National University Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 30 studies in Hematologic Neoplasms with a site in Korea, Republic of — 8 open to participants now, 11 under way, 3 of them phase 3. Hematologic Neoplasms · Korea, Republic of.

Planned enrollment
11th of 25
88 · median 81
Started
2017
the only one that year
Phase 2
10 of 30
4 open now
Registered
16th of 30
by date
Lead sponsor
3 of 30
Seoul National University Hospital

Among the 30 studies in Hematologic Neoplasms with a site in Korea, Republic of, this one is the 11th largest by planned enrollment of the 25 interventional ones that give a count, is the only one that started in 2017, is one of 10 in phase 2, and was the 16th registered.

Hematologic Neoplasms

1,444 studies on the registry are indexed under Hematologic Neoplasms; 420 are open to participants now.

Browse Hematologic Neoplasms studies →

Open to participants now

8 of the 30 studies in Hematologic Neoplasms with a site in Korea, Republic of are open now. Recruiting first, the newest first:

3 more — sign in →

All 8 open studies →

A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →

Who these studies take

Of the 313 Hematologic Neoplasms studies recruiting now, 208 (66%) set no upper age limit and 78 (25%) stop at 75 or younger; 80 take children under 18; 34 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 30 studies in Hematologic Neoplasms with a site in Korea, Republic of, or all of them as a file.
02

Study 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

Read the 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.

03

Conditions studied

  • Hematologic Neoplasms
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
88 participants (estimated)

Study arms

  • Experimental
    Cholecalciferol

    Cholecalciferol 5mg (200,000 IU)

    Drug: Cholecalciferol

  • No intervention
    Usual care

    Usual care

Interventions

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

    Also known as: Caldiferol

06

What researchers measure

Primary outcomes

  1. Chronic GVHD

    Events will be graded according to IBMTR criteria

    Time frame: Up to 1 year

Secondary outcomes

  1. Acute GVHD

    Events will be graded according to IBMTR criteria

    Time frame: Up to 100 days

  2. Vitamin D deficiency

    Severity and incidence of Vitamin D deficiency

    Time frame: Up to 1 year

  3. 25(OH)D3

    Serum concentration of 25(OH)D3

    Time frame: Up to 1 year

07

Study locations

1 of 1 sites recruiting
  • Seoul National University Hospital
    Seoul, 03080, Korea, Republic of
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2017 (actual). Primary completion is estimated for Dec 2018, 14 months after the start.

Of 114 non-industry phase 2 interventional studies under Hematologic Neoplasms, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 42 and three quarters within 95. This study's planned 14 months is below that.

Counting every sponsor, half of 136 studies reached it within 57 months; a quarter within 40 and three quarters within 94.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 22, 2017
First posted
Oct 25, 2017
StartActual
Oct 1, 2017
Primary completionEst.
Dec 2018
CompletionEst.
Dec 2019
Last update
Oct 25, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 25, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03320915
Collaborators
Seoul National University
Responsible party
Youngil Koh (Principal Investigator, Seoul National University Hospital) — Principal investigator
First posted
Oct 25, 2017
Start date
Oct 1, 2017
Primary completion
Dec 2018 (estimated)
Completion
Dec 2019 (estimated)
Last update
Oct 25, 2017

Study contacts

Jae Hyun Kim
Contact
jaerung90@gmail.com
82-2-2072-0335
Youngil Koh, M.D.
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Cholecalciferol

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