Vitamin D Deficiency
Conditions
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTvitamin 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.
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients undergoing allogeneic stem cell transplantation at the Leukemia/BMT Program of British Columbia. 2. Age greater than or equal to 18 years. 3. Able to provide written informed consent.
Exclusion criteria
1. Hypercalcemia, hypervitaminosis D, or allergic/ sensitive to vitamin D. 2. Not meeting eligibility criteria to proceed with allogeneic stem cell transplantation as per the Leukemia/BMT Program of BC.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the efficacy of 100,000 IU vitamin D3 prior to aHSCT | 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. |
Countries
Canada
Contacts
Primary ContactNicola Bai
Backup ContactRaewyn Broady, MBChB
Outcome results
None listed