NCT03534674

Vitamin D3 Supplementation for AlloHSCT-RCT

Validating a Vitamin D3 Supplementation Regimen Among Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vitamin D Deficiency

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-06-15
• Primary completion: 2019-06-15
• Completion: 2019-12-15
• First posted: 2018-05-23
• Last updated: 2018-05-23

Locations

1 site across 1 country: Canada