Vitamin D3 Supplementation for AlloHSCT-RCT
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|ClinicalTrials.gov Identifier: NCT03534674|
Recruitment Status : Not yet recruiting
First Posted : May 23, 2018
Last Update Posted : May 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Vitamin D Deficiency||Dietary Supplement: vitamin D3||Not Applicable|
This is a randomized non-blinded single centre prospective clinical trial designed to validate 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.
84 patients will be enrolled. Following completion of all baseline data collection, participants will be randomized 1:1 to the intervention group or the control group on the admission day for aHSCT
Patients in the intervention group will receive a single oral loading dose of 100,000 IU vitamin D3, with subsequent vitamin D3 2000 IU daily. Patients assigned to the control group will receive our current standard of care, 2000 IU vitamin D3 daily.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Validating a Vitamin D3 Supplementation Regimen Among Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation|
|Estimated Study Start Date :||June 15, 2018|
|Estimated Primary Completion Date :||June 15, 2019|
|Estimated Study Completion Date :||December 15, 2019|
Participants 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.
Dietary Supplement: vitamin D3
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.
No Intervention: Control
Participants assigned to the control group will be advised to take our current vitamin D regimen (2000 IU vitamin D3 daily).
- To assess the efficacy of 100,000 IU vitamin D3 prior to aHSCT [ Time Frame: 1 year ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03534674
|Contact: Nicola Bai||604-875-4111 ext firstname.lastname@example.org|
|Contact: Raewyn Broady, MBChB||604-875-4863||RBroady@bccancer.bc.ca|
|Canada, British Columbia|
|Vancouver General Hospital|
|Vancouver, British Columbia, Canada, V5Z1M9|
|Principal Investigator:||Raewyn Broady, MBChB||British Columbia Cancer Agency|