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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
Sponsor:
Information provided by (Responsible Party):
Raewyn Broady, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Dietary Supplement: vitamin D3 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

Arm Intervention/treatment
Experimental: 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.
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).



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Nicola Bai 604-875-4111 ext 69013 nicola.bai@bccancer.bc.ca
Contact: Raewyn Broady, MBChB 604-875-4863 RBroady@bccancer.bc.ca

Locations
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Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z1M9
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Raewyn Broady, MBChB British Columbia Cancer Agency

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Responsible Party: Raewyn Broady, Clinical Associate Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT03534674     History of Changes
Other Study ID Numbers: H17-03264
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents