- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03202849
A Randomized Trial of Vitamin D Supplementation With or Without Vitamin A in Stem Cell Transplantation
A Randomized Double Blinded Trial of Vitamin D Supplementation With or Without Vitamin A Supplementation in Allogeneic Stem Cell Transplantation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigators' preliminary data suggest that low levels of vitamin A directly impact risk of mucosal barrier injury laboratory-confirmed bloodstream infection (MBI-LCBI) and they believe supplemental vitamin A at the time of hematopoietic stem cell transplantation (HSCT) can reduce the risk of MBI-LCBI and gastrointestinal graft versus host disease (GI GVHD). In addition, the investigators' preliminary data suggest that a significant number of patients requiring HSCT have vitamin D deficiency even prior to transplantation, and that persistent and newly developed deficiency post-HSCT resulted in worse outcomes.
This study is a comparison of vitamin D supplementation comparing a single large dose of vitamin D "stoss therapy" with a placebo in the standard care arm with supplementation with single large doses of both vitamins D and A in the experimental arm. Participants will be randomly assigned to either the standard care arm or the experimental arm.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
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Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Scheduled for allogeneic stem cell transplant
- Vitamin D level < 50 ng/ml
- Vitamin A level < 75th centile for age
- Able to tolerate enteral vitamin dose administration
Exclusion Criteria:
- History of pathologic fractures
- Known history of nephrocalcinosis or nephrolithiasis
- Current granulomatous disease
- ALT > 10X ULN for age prior to administration of vitamin A
- Ongoing raised intracranial pressure
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vitamin D and A Supplementation
Participants receive a single dose of vitamin D and a single dose of vitamin A prior to HSCT.
|
A single dose of Vitamin A and Vitamin D will be given.
|
Active Comparator: Vitamin D Supplementation with Placebo
Participants receive a single dose of vitamin D and a single dose of placebo prior to HSCT.
|
A single dose of Vitamin D plus a placebo will be given.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
GI GVHD
Time Frame: 100 days after transplant
|
Incidence of acute GI GVHD at day +100 after transplant.
GVHD will be graded by the treating physician as per the modified Glucksberg criteria.
|
100 days after transplant
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MBI-LCBI
Time Frame: 100 days after transplant
|
Incidence of MBI-LCBI at day +100 after transplant.
|
100 days after transplant
|
Treatment Related Mortality
Time Frame: 100 days after transplant
|
Treatment related mortality at day +100 after transplant.
|
100 days after transplant
|
Overall Survival
Time Frame: 1 year after transplant
|
Overall survival at 1 year after transplant.
|
1 year after transplant
|
Collaborators and Investigators
Investigators
- Principal Investigator: Stella Davies, MBBS, PhD, MRCP, Children's Hospital Medical Center, Cincinnati
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-9480
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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