Vitamin D3 Supplementation for AlloHSCT-RCT
Validating a Vitamin D3 Supplementation Regimen Among Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
1 other identifier
interventional
84
1 country
1
Brief Summary
This study is to assess whether a single oral loading dose of 100,000 IU vitamin D3 prior to allogeneic hematopoietic stem cell transplant (aHSCT) can achieve optimal 25 hydroxy-vitamin D3(25-OH-D3) levels (\>75nmol/L) at one month post aHSCT, and maintain adequate levels for at least three months, compared to our standard practice of 2000 IU vitamin D3 daily. 25-OH-D3 levels will be measured prior to vitamin D3 supplementation, and 30 as well as 100 days post vitamin D supplementation. We hypothesize that the intervention will prevent vitamin D insufficiency or deficiency in aHSCT recipients, therefore benefit aHSCT-associated morbidity, including osteoporosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2018
CompletedFirst Posted
Study publicly available on registry
May 23, 2018
CompletedStudy Start
First participant enrolled
June 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2019
CompletedMay 23, 2018
May 1, 2018
1 year
May 11, 2018
May 11, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
To assess the efficacy of 100,000 IU vitamin D3 prior to aHSCT
To assess the efficacy (the proportion of patients achieving sufficient serum 25-OH-D3 level) after a single oral loading dose of 100,000 IU vitamin D3 prior to aHSCT, with subsequent vitamin D3 2000 IU daily, in preventing vitamin D insufficiency/deficiency in the first 100 days post-aHSCT.
1 year
Study Arms (2)
Intervention
EXPERIMENTALParticipants assigned to the intervention group will receive a single oral loading dose of 100,000 IU vitamin D3 on the day of hospital admission for aHSCT, with subsequent vitamin D3 2000 IU daily.
Control
NO INTERVENTIONParticipants assigned to the control group will be advised to take our current vitamin D regimen (2000 IU vitamin D3 daily).
Interventions
a single oral loading dose of 100,000 IU vitamin D3 on the day of hospital admission for aHSCT, then 2000 IU vitamin D3 daily.
Eligibility Criteria
You may qualify if:
- Patients undergoing allogeneic stem cell transplantation at the Leukemia/BMT Program of British Columbia.
- Age greater than or equal to 18 years.
- Able to provide written informed consent.
You may not qualify if:
- Hypercalcemia, hypervitaminosis D, or allergic/ sensitive to vitamin D.
- Not meeting eligibility criteria to proceed with allogeneic stem cell transplantation as per the Leukemia/BMT Program of BC.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vancouver General Hospital
Vancouver, British Columbia, V5Z1M9, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raewyn Broady, MBChB
British Columbia Cancer Agency
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Associate Professor
Study Record Dates
First Submitted
May 11, 2018
First Posted
May 23, 2018
Study Start
June 15, 2018
Primary Completion
June 15, 2019
Study Completion
December 15, 2019
Last Updated
May 23, 2018
Record last verified: 2018-05