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Vitamin Supplement
Intervention for Vitamin D Deficiency
N/A
Waitlist Available
Led By Raewyn Broady, MBChB
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Vitamin D Deficiency
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To assess the efficacy of 100,000 IU vitamin D3 prior to aHSCT
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
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.
Group II: ControlActive Control1 Intervention
Participants assigned to the control group will be advised to take our current vitamin D regimen (2000 IU vitamin D3 daily).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
vitamin D3
2010
Completed Phase 4
~4400
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Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,465 Previous Clinical Trials
2,485,413 Total Patients Enrolled
2 Trials studying Vitamin D Deficiency
312 Patients Enrolled for Vitamin D Deficiency
Raewyn Broady, MBChBPrincipal InvestigatorBritish Columbia Cancer Agency
1 Previous Clinical Trials
20 Total Patients Enrolled
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